Protocol

Comparative Dissolution Study procedure

Pharma Operations, Protocol, Quality Assurance, Quality Control

Comparative Dissolution, General Overview

[][]Comparative Dissolution, Oral dosage form like Table & Capsule are more popular than IV/IM(Intravenous/Intramuscular) Injection formulation. From the very beginning, people are most familiar with oral solid dosage form (Tablet, Capsule, Powder etc.) and becoming more popular till today as no special technique or device is not require to administer these products and associated pain is not involved here.

[][]In the period of time its are considered as the most effective and efficient method to treat the patient. This orally taken drugs are dissolved in GI (Gastro Intestinal) fluid and then bioavailable at the systemic circulation as it absorbed here. To measure the bioavailability of a certain drugs (in vivo Analysis, vivo is Latin for “within the living, test perform in living organism) is not accurately possible due to its complex nature.

[][]For this reason, in vitro (vitro is Latin for “within the glass, test perform outside the living organism) methods are followed to measure the dissolution rate of a certain drugs. This method is officially recognized by certain regulatory authority and it(in vitro study) considered most convenient way to develop new formulation of oral solid dosage form.

Comparative Dissolution Consideration

[][]Dissolution method is the best option for the lower strength drug where different strength is proportionally formulated to acquire the biowaiver of certain formulated drug. For a certain product which higher strength bioequivalence study has been carried out and found proportional to the concentration then biowaiver is conceivable to the lower strength.

Dissolution test are considering the most quality control tool for the commercial batch to batch product to monitor its consistency over a certain period of time. It also provides significant information during post approval changes of the certain product as changes made in formulation, manufacturing process and different scale up procedure.

[][]The most physiological factor is considered as the dissolution and solubility of the API and its permeability through the membrane of the GI[Gastro Intestinal] tract. As this measurement is so prone to error due to its complex nature then in vitro study consider the most convenient and reliable procedure to achieve the required target. During development of a certain solid dosage form, dissolution is considered as the best option to determine its quality parameter which have the great impact on the bioavailability of the formulated product.

Comparative Dissolution, Waiver of in vivo bioavailability

[][]BCS system applied in this case so that waiver for in vivo analysis can be assured. BCS [Biopharmaceutical Classification System] is a system which measure the permeability and solubility of drugs in a certain prescribed condition.

[][]The actual aim of BCS is to aid the post approval changes and arranging approval activities based on in vitro data studies.

Go to top

This system has been optimized based on the oral solid dosage unit as most of the market products are available at oral dosage form [More than 50% total market share, US$23.4 Bn in 2021, US$24.7 Bn in 2022 as estimated, growth rate 5.9%).

[][]Waivers[ means giving permission to skip in vivo bioequivalence study] is actually reserved for those products that meet the specific requirements of solubility & permeability & most of the cases rapid dissolve in body fluid.

[][]Using the BCS, appropriate formulation study shall be developed such as Type II drugs designed as Permeable but insoluble, this class is not the actual right candidate for development of a new moiety.

[][]So, solubility shall be developed to acquire the right dissolution profile. Based on the solubility and permeability BCS has classified the four categories of the product as depicted below

Dosage form challenge

[][]Comparison has been drawn from old drug to new drug formulation, where older drugs compare to the current products are more prone to solubilities. Class II compound has been remarkably increased as 30% to 60% where class I compound has down to 40% to 20% where low solubility has the main cause to encounter the issue.

A oral solid dosage form is the preferred option but all time this can’t possible the suspension or solution is continued to prove its existence

[][]Generally a highly soluble active substance and rapidly dissolve dosage form provide better bioavailability and in this case biowaiver can be waived for bioequivalence studies base on its dissolution profile.

[][]If a active substance found low solubility but high permeability then the rate limiting steps of absorption may be consider as dissolution. Most of the cases dissolution profile control the more than one of excipients or special design matrix compounds. So Test condition may be consider as various time frame (10, 15, 20,30, 45 & 6 minutes).

[][]Drugs that are poor soluble in water then various time frame are considered and accepted timeframe is set for dissolution profile. Here USP Type 4 apparatus to be used to develop such type dissolution profile. Most of the time, monograph for combination product is not available at BP or USP the individual monograph shall be used to set the dissolution profile.

Selection of Dissolution Media

Selection of the dissolution media is the vital point to achieve the goal. pH of the media as the key role as all of the dosage form goes to GI[Gastro Intestinal] tract so pH shall be simulate with the GI Tract environment. pH shall be 1.2 to 6.8 which is the physiologic pH range of the body.

Zone	pH
[A]Pre-prandial Stomach	1.8(1~3)
Duodenum	6.0(4~7)
Upper Jejunum	6.5(5.5~7)
Lower Jejunum	6.8(6~7.2)
Upper Ileum	7.2(6.5~7.5)
Lower Ileum	7.5(7~8)
Proximal Colon	(5.5 ~6.5)

[B]Post-prandial Stomach	4.0(3~6)
Duodenum	5.0(4~7)
Upper Jejunum	5.5(5.5~7)
Lower Jejunum	6.5(6~7.2)
Upper Ileum	7.2(6.5~7.5)
Lower Ileum	7.5(7~8)
Proximal Colon	(5.5 ~6.5)

Dissolution Statistics

Different cases obtaining after multipoint dissolution which is calculative as follows:
[][]If Test Product and Reference Product both shows dissolution rate more than 85% within first 15 minutes then no calculation is required, they are considered as similar. If it didn’t achieved then seek for next step.
[][]Seek for f2 value[ f2, similarity factor] if f2>50% then it consider similar then in vivo study is not required.
[][]Difference Factor [f1] is the percentage (%) difference between the two curve at the each time period and also measure the relative error between two curve.

How it works

To determine the difference and similarity factor(f2) following pont shall be noted:
[][]Use the Two different products for study, from each product collect 12 unit [12 unit from Test Product & 12 Unit from Reference Product].

[][]Three time point shall be considered[Exclude Point Zero], only one measurement after 85% shall be measured.
[][]Produced curve shall be similar, f2 values shall be close to 100. Most of the time f2 value more than 50 denote similarity of the two curves as well as equivalence of the two products.

If Three/Four Time points come to the test then following points shall be considered.

[][]The measurement for the Test Product and the Reference product shall be same. Dissolution Time point shall be same for the both product (10,15,20,30,45,60 minutes etc.). Products which tend to faster dissolution (85% dissolve within 30 minutes) then time frame shall be consider as 10, 15, 20, 30 minutes.
[][]Only One measurement shall be consider after completion of 85% dissolution of both sample and reference products.

System Requirements to Perform Comparative Dissolution

Dissolution Activities shall be continued on USP Type I Dissolution apparatus at 100 RPM or USP Type II Apparatus at 50 RPM using 900 ml of different dissolution media mentioned below.
[][]Media Use in Comparative Dissolution
[][]Acid Media: 0.1N HCL or Simulated Gastric Fluid USP without Enzyme
[][]Acetate Buffer pH 4.5
[][]Phosphate Buffer pH 6.8 or Simulated Intestinal Fluid without Enzyme
[][]If both the Test Product and Reference product shows more than 85% dissolution within first 15 minutes then no calculation required. If not meets the above requirements then calculate f2 Value.
[][]If found f2>50, then the profile considered as similar and in vivo study is not required. Minimum 12 unit of each shall be consider for comparative dissolution.

Download Here

Comparative Dissolution Study Protocol

Comparative Dissolution Study procedure Read More »

Performance Qualification of WFI Phase 3

Performance Qualification Protocol, Pharma Operations, Protocol

Performance Qualification of WFI, Purpose

Performance Qualification of WFI, To authenticate and document that the performance of the WFI Generation and Distribution System installed at the WFI & PS plant room (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited is satisfactory in all critical features related to the operational requirements during Phase – 3 study.

Performance Qualification of WFI, Scope

This protocol will be applicable for performing Phase – 3 validation study to verify that the Water For Injection generation and distribution system installed at WFI & PS plant room (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited consistently produce desired quality of Water For Injection over the study period of 01 year.

People also Read

Water For Injection Performance Qualification of Phase 2 Study

Responsibilities

[][]Preparation of the protocol
Validation (Engineering) Department.
[][]Executing the protocol
Validation team along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Chemical test
Quality Control Department
[][]Microbiological Test
Microbiology Department
[][]Data documentation and preparation of the report
Validation (Engineering) department.
[][]Verifying the report
Concerned departmental person.
[][]Providing documentation on the equipment
Related departments i.e. Engineering, Quality Control, Microbiology, Validation.

System And Process Description

System Information

=>Manufacturer : Watertown
=>Capacity : 750 ltr/hr
=>Model : MS750/4T
=>Manufacturer no. : MS1132

The System under test

[][]The Water For Injection system is designed to generate and distribute the desired quantity & quality of Water For Injection to various user points.

Generation system of Water For Injection

[][]The WFI production process consists of purified water evaporation followed by pure steam separation and condensation through four multi-effect water still columns.

[][]Purified water from the storage tank is pressurized through a feed water pump and pre heated in the four pre heaters.

[][]Then, the purified water becomes pure steam in the four multi effect columns by exchanging heat with the plant steam.

[][]There are two condensers in the system. The first condenser is used to cool the pure steam by exchanging heat with the incoming feed water (PW).

[][]Finally, the WFI is produced in second condenser by exchanging heat with the chilled water which is then supplied to the WFI storage tank.

Distribution system of Water For Injection

[][]The WFI is stored in a WFI storage tank of 2000 ltr capacity and is distributed to the user points and circulated within a loop by a high pressure pump.

[][]There is a heat exchanger in the distribution section to sterilize the whole distribution system.

Tests To Be Performed And Sampling Plan

[][]A comprehensive validation study plan has been established where a weekly sampling plan has been developed for Phase-3 study of WFI system for 01 year concerning weekly testing of all main sampling points.

[][]The sampling will be taken one day a week on working days. The acceptance criterion of the tests are stated in the table.

Main Sampling Points

The sampling points of WFI are listed below:

Sl. No.	Sample ID	User point Location	Tests	Microbial Count/ Chemical Tests
01	WSP-1	Final WFI after condenser – 2 (before WFI storage tank).	Next Table	Weekly
02	WSP-2	At supply of WFI Distribution Loop	Next Table	Weekly
03	WSP-3	At return of WFI Distribution Loop	Next Table	Weekly
04	WUSP – 01	WFI Distribution Loop	Next Table	Weekly
05	WUSP – 02	WFI Distribution Loop	Next Table	Weekly
06	WUSP – 03	WFI Distribution Loop	Next Table	Weekly
07	WUSP – 04	Cold User point	Next Table	Weekly

Tests and Acceptance Criteria for Water for Injection

Sl. No.	Tests	Frequency	Acceptance Criteria	Alert Limit	Action Limit
01	Appearance	Daily from each sampling point.	Clear, colorless and odorless liquid.	N/A	N/A
02	Conductivity	Daily from each sampling point.	Not more than 1.1 µS/cm at 20⁰C or Not more than 1.3 µS/cm at 25⁰C	0.7 µS/cm	0.9 µS/cm
03	Total Organic Carbon	Daily from each sampling point.	Not more than 500 ppb	106.4 ppb	135.8 ppb
04	Total Viable Microbial Count	Daily from each sampling point.	Not more than 10 CFU/100 mL	5 CFU/100 mL	8 CFU/100 mL
05	E.coli	Daily from each sampling point.	Must be Absent	N/A	N/A
06	Staphylococcus aureus	Daily from each sampling point.	Must be Absent	N/A	N/A
07	Pseudomonas aeruginosa	Daily from each sampling point.	Must be Absent	N/A	N/A
08	Salmonella spp	Daily from each sampling point.	Must be Absent	N/A	N/A
09	Bacterial Endotoxins	Daily from each sampling point.	Less than 0.25 EU /mL	N/A	N/A

[][]Performance Qualification shall be considered acceptable when all the conditions above have been met.
[][]Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component/system.

Conclusion

[][]The results of the Phase – 3 study, as per the qualification protocol are recorded & analyzed.

[][]The observed parameters/tests and subsequent analytical results show that the Water For Injection Generation and Distribution System Complies/Does Not Comply as per the predetermined acceptance criteria.
[][]Hence, the Water For Injection Generation and Distribution is / is not qualifying the Phase – 3 study of Performance Qualification and the System can be / cannot be used for production purpose and continued to regular monitoring by Quality Control and Microbiology department.

Download Here

Performance Qualification Protocol of WFI Phase 3

Performance Qualification of WFI Phase 3 Read More »

Water For Injection Performance Qualification in Phase 2 Study

Performance Qualification Protocol, Pharma Operations, Protocol

Water For Injection Performance Qualification, Purpose

Water For Injection Performance Qualification, To validate and archive that the exhibition of the WFI Generation and Distribution System introduced at the WFI and PS plant room (rooftop top) of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) is agreeable in all basic elements connected with the functional necessities during Phase – 2 Study.

Water For Injection Performance Qualification, Scope

This Protocol will be relevant for performing Phase – 2 study to check that the Water For Injection generation and conveyance framework introduced at WFI and PS plant room (rooftop top) of Cephalosporin Block of XX Pharmaceuticals Limited, reliably produce wanted nature of Water For Injection over the review time of 20 continuous working days.

People Also Read

Water For Injection Performance Qualification Phase I Study

Responsibilities

System & Processing

System Information
Manufacturer : Watertown
Capacity : 750 ltr/hr
Model : MS750/4T
Manufacturer no. : MS1132

The System under test

The Water For Injection system is designed to generate and distribute the desired quantity & quality of Water For Injection to various user points.

Generation system of Water For Injection

[][]The WFI manufacturing process consists of purified water evaporation followed by pure steam separation & condensation through four multi-effect water still columns.

[][]Purified water from the storage tank is pressurized through feed water pump & pre heated in the four pre-heaters.

[][]Then, the purified water becomes pure steam in the four multi effect columns by exchanging heat with the plant steam.

[][]There are two condensers in the system. The first condenser is used to cool the pure steam by exchanging heat with the incoming feed water (PW).

[][]Finally, the WFI is produced in second condenser by exchanging heat with the chilled water which is then supplied to the WFI storage tank.

Distribution system of Water For Injection

The WFI is stored in a WFI storage tank of 2000 L capacity and is distributed to the user points and circulated within a loop by a high pressure pump. There is a heat exchanger in the distribution section to sterilize the whole distribution system.

Test to be perform & Sampling

[][]A comprehensive validation study plan has been established where a daily sampling plan has been developed for Phase-2 study of WFI system for 20 consecutive working days concerning daily testing of all main sampling points.The acceptance criterion of the tests are stated in the table of section.

Main Sampling Points

The sampling points of WFI are listed below:

Sl. No.	Sample ID	Room Name	Tests	Microbial Count/ Chemical Tests
01	WSP-1	WFI and Pure Steam plant room	Below Table	Daily
02	WSP-2	WFI and Pure Steam plant room	Below Table	Daily
03	WSP-3	WFI and Pure Steam plant room	Below Table	Daily
04	WUSP – 01	Vial Washing & Sterilization	Below Table	Daily
05	WUSP – 02	Laundry & Wash	Below Table	Daily
06	WUSP – 03	Wash Bay	Below Table	Daily
07	WUSP – 04	Laundry & Wash	Below Table	Daily

Tests and Acceptance Criteria for Water for Injection (Based on Current USP 37)

Sl. No.	Tests	Frequency	Acceptance Criteria	Alert Limit
01	Appearance	Daily from each sampling point.	Clear, colorless and odorless liquid.	Not Available
02	Conductivity	Daily from each sampling point.	Not more than 1.1 µS/cm at 20⁰C or Not more than 1.3 µS/cm at 25⁰C	Not Available
03	Total Organic Carbon	Daily from each sampling point.	Not more than 500 ppb	Not Available
04	Total Viable Microbial Count	Daily from each sampling point.	Not more than 10 CFU/100 mL	Not Available
05	E.coli	Daily from each sampling point.	Must be Absent	Not Available
06	Staphylococcus aureus	Daily from each sampling point.	Must be Absent	Not Available
07	Pseudomonas aeruginosa	Daily from each sampling point.	Must be Absent	Not Available
08	Salmonella spp	Daily from each sampling point.	Must be Absent	Not Available
09	Bacterial Endotoxins	Daily from each sampling point.	Less than 0.25 EU /mL	Not Available

Reference Documents

Sl. No.	Title of the Document	Document No.
01	WHO Good Manufacturing Practices: water for pharmaceutical use.	WHO Technical Report Series, No. 929, 2005
02	WHO Expert Committee on Specifications for Pharmaceutical Preparations.	WHO Technical Report Series No. 970, 2012
03	United States Pharmacopeia 37	Not Available

Conclusion

[][]The results of the Phase – 2 study, as per the qualification protocol are recorded & analyzed. The observed parameters/tests and subsequent analytical results show that the Water For Injection Generation and Distribution System Complies/Does Not Comply as per the predetermined acceptance criteria.

[][]Hence, the Water For Injection Generation and Distribution is / is not qualifying the Phase – 2 study of Performance Qualification and the System can be / cannot be used for production purpose and continued to Phase – 3 study.

Download Here

Water For Injection Performance Qualification Phase 2 Study

Water For Injection Performance Qualification in Phase 2 Study Read More »

WFI Performance Qualification, Phase-I Study

Performance Qualification Protocol, Pharma Operations, Protocol

WFI Performance Qualification, Purpose

WFI Performance Qualification, To authenticate and document that the performance of the WFI Generation and Distribution System installed at the WFI & PS plant room of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) is satisfactory in all critical features related to the operational requirements during Phase – 1 (Investigational Phase) study.

WFI Performance Qualification, Scope

This protocol will be applicable for performing Phase -1 validation study to verify that the Water For Injection generation and distribution system installed at the utility area (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited, consistently produce desired quality of Water For Injection over the study period of 20 consecutive working days.

People Also Read

Pure Steam System Performance Qualification

Responsibilities

[][]Preparation of the protocol
=>Validation (Engineering) Department.
[][]Executing the protocol
=>Validation team along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Chemical Test
=>Quality Control Department
[][]Microbiological Test
=>Microbiology Department
[][]Data documentation and preparation of the report
=>Validation (Engineering) department.
[][]Verifying of the report
=>Concerned departmental person.
[][]Providing documentation on the equipment
=>Related departments i.e. Engineering, Quality Control, Microbiology, Validation.

System And Process Description

=>System Information

=>Manufacturer : Watertown
=>Capacity : 750 ltr/hr
=>Model : MS750/4T
=>Manufacturer no. : MS1132

The System under test

The Water For Injection system is designed to generate and distribute the desired quantity & quality of Water For Injection to various user points.

Generation system of Water For Injection

[][]The WFI production process consists of purified water evaporation followed by pure steam separation and condensation through four multi-effect water still columns.

[][]Purified water from the storage tank is pressurized through a feed water pump and pre heated in the four pre heaters.

[][]Then, the purified water becomes pure steam in the four multi effect columns by exchanging heat with the plant steam.

[][]There are two condensers in the system. The first condenser is used to cool the pure steam by exchanging heat with the incoming feed water (PW).

[][]Finally, the WFI is produced in second condenser by exchanging heat with the chilled water which is then supplied to the WFI storage tank.

Distribution system of Water For Injection

[][]The WFI is stored in a WFI storage tank of 2000 ltr capacity and is distributed to the user points and circulated within a loop by a high pressure pump.

[][]There is a heat exchanger in the distribution section to sterilize the whole distribution system.

Tests To Be Performed And Sampling Plan

[][]A complete validation study plan has been designed in accordance with the Validation Master Plan. In addition, a daily sampling plan has been also developed for Phase-1 study of WFI system for 20 consecutive working days concerning daily testing of all main sampling points .

[][]The acceptance criterion of each test is stated in the next table.
[][]Alert and action limits will be calculated using following formula after getting the test results and data:
=>Alert limit = Average value + 2σ
=>Action limit = Average value + 3σ

Main Sampling Points

The sampling points of WFI are listed below:

Sl. No.	Sample ID	Room Number	User point Location	Tests	Microbial Count & Chemical Tests
01	WSP-1	SRT001	Final WFI after condenser – 2 (before WFI storage tank).	Mention on next Table	Daily
02	WSP-2	SRT001	At supply of WFI Distribution Loop	Mention on next Table	Daily
03	WSP-3	SRT001	At return of WFI Distribution Loop	Mention on next Table	Daily
04	WUSP – 01	SPR054	WFI Distribution Loop	Mention on next Table	Daily
05	WUSP – 02	SPR040	WFI Distribution Loop	Mention on next Table	Daily
06	WUSP – 03	SMB010	WFI Distribution Loop	Mention on next Table	Daily
07	WUSP – 04	SPR040	Cold User point	Mention on next Table	Daily

Tests And Acceptance Criteria For Water For Injection

Sl. No.	Tests	Frequency	Acceptance Criteria	Alert Limit
1	Appearance	Daily	Clear, colorless and odorless liquid.	N/A
2	Conductivity	Daily	Not more than 1.1 µS/cm at 20⁰C or Not more than 1.3 µS/cm at 25⁰C	N/A
3	Total Organic Carbon	Daily	Not more than 500 ppb	N/A
4	Total Viable Microbial Count	Daily	Not more than 10 CFU/100 mL	N/A
5	E.coli	Daily	Must be Absent	N/A
6	Staphylococcus aureus	Daily	Must be Absent	N/A
7	Pseudomonas aeruginosa	Daily	Must be Absent	N/A
8	Salmonella spp	Daily	Must be Absent	N/A
9	Bacterial Endotoxins	Daily	Less than 0.25 EU /mL	N/A

Test Records

All the test reports of chemical and microbiological tests are attached with the report as attachment.

Reference Documents

Sl. No.	Title of the Document	Document No.
01	WHO Good Manufacturing Practices: water for pharmaceutical use.	WHO Technical Report Series, No. 929, 2005
02	WHO Expert Committee on Specifications for Pharmaceutical Preparations.	WHO Technical Report Series No. 970, 2012
03	United States Pharmacopeia	N/A

Download Here

WFI Performance Qualification, Phase-I Study Protocol

WFI Performance Qualification, Phase-I Study Read More »

Vial Washing Machine Performance Qualification

Performance Qualification Protocol, Pharma Operations, Protocol

Vial Washing Machine Performance Qualification, Purpose

Vial Washing Machine Performance Qualification, To authenticate and document that the performance of the Vial Washing Machine of Sterile Production area (Cephalosporin Block) of XX Pharmaceutical Limited (XPL) is satisfactory in all critical aspects related to the operational requirements during washing of vials. This protocol describes the performance qualification procedures of the Vial Washing Machine manufactured by Tofflon, China.

Vial Washing Machine Performance Qualification, Scope

This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on 7.5 ml, 15 ml and 30 ml vials which will be washed by the Vial Washing Machine installed in the Sterile Production area of Cephalosporin Block of XX Pharmaceutical Limited.

People Also Read

Vial Filling Machine Performance Qualification

Responsibilities

[][]Preparation of the protocol

Validation (Engineering) Department with the assistance of Microbiology, Engineering and Maintenance department.
Executing the protocol

[][]Validation (Engineering) Department along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Microbiological Challenge Test

Microbiology department
[][]Chemical Tests

Quality Control Department
[][]Data documentation and preparation of the report

Validation (Engineering) department.
[][]Verifying of the report

Concerned departmental person.
[][]Providing documentation on the equipment

Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.

System And Process Description

[][]Equipment Information
=>Manufacturer : Tofflon, China
=>Capacity : 6000 – 9000 vials/hr.
=>Model : QCLX60
=>Serial no. : YF2014-078A

[][]The Equipment under test
The vials from the box are placed on the infeed conveyor belt and are showered by recycled WFI at first. Then, these are cleaned in the ultrasonic bath and transferred to the grippers. The infeed rotary screw transports the vials from the housing to the grippers. There are total twenty stations where 60 vials are washed using following sequence:
=>Internal blowing with compressed air.
=>Internal and external spraying with recycled WFI at ambient temperature.
=>Internal blowing with sterile compressed air.
=>Internal and external spraying with fresh WFI.
=>Internal blowing with compressed air.
=>Internal and external blowing with sterile compressed air.
=>The supply lines are equipped by filter with the following retention grade: compressed air 0.22 µm, recycled WFI 10 µm and 5 µm, and fresh WFI 0.22 µm.

Checking Parameters

The PQ of Vial Washing Machine will be carried out to evaluate the following conditions to confirm the sterilization conditions:
i) Riboflavin Test.
ii) Particulate Matter Test.
iii) Bacterial Endotoxin Test.
iv) Washing Efficiency Test.

Study Procedure:

[][]Riboflavin Test: Take the Vials and do the decartoning and check for any Physical deformity or damage. A 0.2 gm riboflavin sodium phosphate per liter of purified water solution is prepared.

[][]Take 60 vials, mark with the permanent marker and spray the interior and exterior of the vials with the solution so that every vial is properly moistened with the solution and keep for overnight.

[][]Next morning dry the vials in oven for 2 hrs at 150 °C. After that, rinse the vials with phosphate buffer solution of pH 7.0 and measure the absorption in a UV-VIS spectrophotometer using 1 cm cell at a wavelength 266 nm by setting the limit between 230 nm and 350 nm.

[][]Use phosphate buffer solution of pH 7.0 as blank. Record the spectrum. Place the marked 60 Vials with these and run the machine as per SOP and collect these vials after washing.

[][]Take these vials again; repeat the procedure in order to confirm the presence of any riboflavin on vials.
The test will be repeated at minimum and maximum speed of washing machine for each of three vials’ sizes 7.5ml, 15ml and 30ml.

[][]The results of above test will be attached with the report and will be accepted if met the acceptance criteria.

Acceptance Criteria:

Riboflavin content must be absent in all the spiked vials after washing.

Particulate Matter Test:

[][]10 gm of charcoal is dissolved in 1000 gm WFI to make 1% charcoal slurry.

[][]Approximately 0.1 ml of charcoal slurry is used to spike each of 60 vials by swirling the vial to coat the inner surface and evaporate the solution to dryness at room temperature.

[][]Spiked test vials with charcoal are marked in series with permanent marker on the outer surface.

[][]Take the particle count of the vials before washing. After that, load these vials on the tray and run the machine according to the SOP No.____________________.

[][]The test must be performed at minimum and maximum speed of washing machine for each of three vials’ sizes 7.5ml, 15ml and 30ml.
[][]The results of above test will be attached with the report and will be accepted if met the acceptance criteria.

Acceptance Criteria:

Vials should be free from foreign particle & fibers on visual inspection. 10µ particles should not be more than 25 and 25µ particles should not be more than 3.

Bacterial Endotoxin Test:

[][]Add 100 endotoxin units into 10 vials and allow them to dry at 45 – 50°C. Mark these spiked vials with permanent marker on outer surface.

[][]Separate 10 vials are used for each of above tests. About 3000 vials of selected size are loaded on the feed belt and vial washing machine is operated as per the standard operating procedure.

[][]Place the spiked vials marked with permanent marker in between the other vials while machine is running. Collect the marked vials after washing and store properly to avoid the other contamination from environment.

[][]These spiked vials are analyzed separately. It should be done three times for each vial size. The test must be performed at minimum and maximum speed of washing machine for each of three vials’ sizes 7.5ml, 15ml and 30ml.
[][]The results of above test will be attached with the report and will be accepted if met the acceptance criteria.

Acceptance Criteria:

Vials should comply endotoxin limit within 0.25 EU/vial.

[][]Following parameter also maintained as per protocol

=>Deviation And Failure Investigation Summary

=>Documentation Requirements

=>Report Summary

Conclusion

The performance qualification Complies / Does Not Comply with the acceptance criteria taken above and the results obtained are attached with the protocol.
The Vial Washing Machine of Sterile Production area of Cephalosporin Block is / is not qualifying the Performance Qualification test as per this Protocol. Therefore, the Vial Washing Machine can be / cannot be used for production operation.

Download Here

Vial washing Machine Performance Qualification Protocol

Vial Washing Machine Performance Qualification Read More »

Laminar Air Flow Performance Qualification

Performance Qualification Protocol, Pharma Operations, Protocol

Laminar Air Flow Performance Qualification, Purpose

Laminar Air Flow Performance Qualification, To authenticate and document that the performance of the Laminar Air Flow unit of Sterile Production area of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) meets the user’s requirements of XPL Pharmaceutical Limited.

Laminar Air Flow Performance Qualification, Scope

This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on the Laminar Air Flow Unit, which has been installed above the turn table after Depyrogenation Tunnel in Room of Sterile Production floor of Cephalosporin Block.

People Also Read

Laminar Air Flow Operational Qualification

Responsibilities

Preparation of the protocol
-Engineering Department with the assistance of Validation team.
Executing the protocol
-Validation (Engineering) Department along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
Microbiological Test
-Microbiology department
Data documentation and preparation of the report
-Validation (Engineering) department.
Verifying of the report
-Concerned departmental person.
Providing documentation on the equipment
-Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.

Performance testing

Air borne particle count test
=>Purpose: the purpose of this test is to ensure that the air borne particles are under the acceptance limit.
=>Test method: carry out the particle count test according to respective sop. Perform the test at rest and in operation conditions for 3 consecutive working days at each condition. Record the results in appendix – 1.
=>Test instrument id:
=>Acceptance criteria: the particle count specifications under the laminar air flow unit should meet the specification of room class a.

People Also Read

Laminar Air Flow Installation Qualification

Microbial Count test

Purpose: To ensure that the microbial count meets the specification of clean room class A.
Test Method: Perform the test at rest and in operation conditions for 3 consecutive working days at each condition. All results must be recorded on the appropriate forms of monitoring methodology and be compared with the alarm and specified action limits. The limits of sterile and non-sterile applications are specified below. Details are to be recorded in Appendix – 2.
Test Instrument ID: N/A
Acceptance Criteria: The microbial count must meet the clean room class – A specifications.

Sl. No.	Room Class	Air Sample (cfu/m3)	Settle Plates (cfu/4 hours)	Contact Plate (cfu/plate)
01	A	<1	<1	<1
02	B	10	5	5

Deviation And Failure Investigation Summary

Record in the column below any deviations or failures that occurred during the PQ exercise.

Deviation/ Failure	Deviation/ FailureDescription and assessment of impact on validation	Initial	Date
1
2
3

Reference Documents

Sl. No.	Title of the Document	Document No.
01	Clean rooms and associated controlled environments part 1: classification of air cleanliness	ISO 14644 – 1
02	Clean rooms and associated controlled environments Part 3: Test methods	ISO 14644 – 2
03	Standard Operating Procedure For Environmental Monitoring (Microbial & Particle Count)	In-house SOP

Conclusion

The performance qualification complies / does not comply with the acceptance criteria taken above and the obtained results are attached with the protocol.
The laminar air flow unit of sterile production area of cephalosporin block is / is not qualifying the performance qualification test as per this protocol.
Hence, the system can be / cannot be used for normal operation.

Download Here

Laminar Air Flow Performance Qualification Protocol

Laminar Air Flow Performance Qualification Read More »

Laminar Air Flow Operational Qualification

Operational Qualification, Pharma Operations, Protocol

Laminar Air Flow Operational Qualification, Purpose

Laminar Air Flow Operational Qualification, To authenticate and document that the Laminar Air Flow Unit of Sterile production area of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) operates as designed and intended. The operational parameters should be consistent with the requirements for the manufacturing process.

Laminar Air Flow Operational Qualification, Scope

This Operational Qualification (OQ) is to be performed against agreed acceptance criteria on the Laminar Air Flow Unit installed above the turn table after Depyrogenation Tunnel in Room of Sterile Production floor of Cephalosporin Block. The scope will include the verification of previously calibrated instruments and the availability of operational, maintenance and cleaning procedures.

Responsibility

Preparation of protocol
-Engineering Department.
Executing the protocol
-Engineering department or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
Providing documentation of the equipment
-Related departments i.e. Engineering Production, Validation or other appropriate departments and manufacturer.
Data documentation and preparation of the report
-Raw data documentation is the responsibility of those conducting the validation. Preparation of the report and incorporation of data will be the responsibility of the Engineering Department.

Background

Project Description & Related issues
[][]This Laminar Air Flow Unit has been installed in the year 20xx in the sterile production area of Cephalosporin Block for dispensing of raw materials.

Purchasing Information

[][]Manufacturer: GUSU
[][]Local Agent: LS Techno Trade
[][]Model Number: GMP Standard

System Description

[][]A Laminar Air Flow Unit is used to provide unidirectional air flow. Grade A is ensured under LAF using H14 HEPA filter.

[][]A blower is used to circulate the air. The air flow direction of this LAF is vertical.

[][]There is a differential pressure gauge to see the differential pressure across the filters which indicate the blockage of filters.

Verification of Sops

[][]The standard operating procedure for operation and cleaning procedure of Laminar Air Flow Unit must be at least in draft format before commencement of OQ. The necessary information are recorded in the following table:

Sl. No.	SOP Name	Effective Date	Acceptable (Yes/ No)	Initials with date
01	Operation and Cleaning of Laminar Air Flow Unit.
02

Verification of Training

Training should have been given regarding operation, maintenance and cleaning of Laminar Air Flow Unit to all operators and must be documented.
The documentation status is to be recorded in the following tables.
The training is to be recorded in the following tables.

Trainer Name	Training course/SOP Name	Trainee Name	Initials	Date

Operational testing

Verification of start-up and normal sequence of operation
Record results of checks in the following table:

Criterion No.	Action to be taken	Acceptance Criteria
01	Switch ON the main power.	The voltage will be shown on the display.
02	Switch ON the blower by pressing the ON button.	The blower has to be ON and air will start flowing vertically.
03	Differential Pressure gauge for HEPA Filter is functioning properly.	The differential pressure gauge should show pressure from zero to positive direction.

Smoke Test

Purpose: The purpose of the smoke test is to justify the airflow direction under the HEPA Filter is unidirectional.
Test Method:
The smoke test will be performed by ______________________ According to the SOP No. _____________________________.
Test Equipment/Material: Dry Ice and water.
Acceptance Criteria: Airflow direction is unidirectional and vertical. Attach a copy of the report of Smoke test.

Filter Integrity Test

Purpose: Filter Integrity test is performed using Poly Alpha Olephin (PAO) to check any leakage of the filter.
Test Method: The test is performed by ____________________ according to the SOP NO. ______________________________.
Test Equipment: PAO generator, Optical Photometer.
Acceptance Criteria: Any leakage greater than 0.01% of the upstream challenge aerosol concentration is considered unacceptable and wants repairs and resetting.
Attach a copy of HEPA filter integrity test certificate in attachment.

Air Velocity Test

Purpose: The purpose of this test is to ensure the air velocity for laminar flow.

Test Method:
Measure the air velocity under each HEPA filter of the equipment at the distance of 6” below the filter grill and record the velocity at 5 locations (Shown in following figure) and take the average reading with the anemometer.
Measure the air velocity under each HEPA filter of the equipment at the operation level and record the velocity at 5 locations (Shown in following figure) and take the average reading with the anemometer.
Test Equipment: Calibrated anemometer.
Acceptance Criteria: Measured air velocity should be in the range of 0.36 m/sec ~ 0.54 m/sec.
Result:

No. 1 HEPA

No. 2 HEPA result shall be plotted.

Conclusion

[][]The Operational Qualification of Laminar Air Flow Unit of Cephalosporin Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained have been filled up in the respective table of each test.
[][]The Laminar Air Flow Unit of Cephalosporin Block is / is not qualifying the Operational Qualification test as per this Protocol. Hence, the system can be / cannot be used for Performance Qualification.

Download Here

Laminar Air Flow Operational Qualification

Laminar Air Flow Operational Qualification Read More »

Laminar Air Flow Installation Qualification

Pharma Operations, Protocol

Laminar Air Flow Installation Qualification, Purpose

Laminar Air Flow Installation Qualification, To verify and document that the Laminar Air Flow Unit of Sterile Area of Cephalosporin Block is designed, built and installed according to XX Pharmaceuticals Limited’s demand and manufacturer specifications and that documentation is compiled to verify the integrity of the installation.

Laminar Air Flow Installation Qualification, Scope

This Installation Qualification (IQ) is to be performed against agreed acceptance criteria on the Laminar Air Flow Unit installed above the turn table after Depyrogenation Tunnel in Room of Sterile Production floor of Cephalosporin Block. The scope will include assessment of equipment design and installation, connection of utilities, presence and function of instruments.

People Also Read

HVAC Operational Qualification

Responsibilities

[][]Preparation of protocol
=>Engineering Department.
[][]Executing the protocol
=>Engineering department or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Providing documentation on the equipment
=>Related departments i.e. Engineering Production, Validation or other appropriate departments and manufacturer
[][]Data documentation and preparation of the report
=>Raw data documentation is the responsibility of those conducting the validation. Preparation of the report and incorporation of data will be the responsibility of the Engineering Department.

Background

[][]Project Description & Related issues
=>This Laminar Air Flow Unit has been installed in the year 20xx in the sterile production area of Cephalosporin Block for dispensing of raw materials.

Purchasing Information

Item/ Brand

=>Manufacturer: GUSU
=>Local Agent: Precisa Techno Trade
=>Model Number: Standard

System Description

A Laminar Air Flow Unit is used to provide unidirectional air flow. Grade A is ensured under LAF using H14 HEPA filter. A blower is used to circulate the air. The air flow direction of this LAF is vertical. There is a differential pressure gauge to see the differential pressure across the filters which indicate the blockage of filters.

Following Document Shall be noted:
[][]Verification of Installation
[][]Design Documentation
=>General Characteristics
=>Engineering Specifications
[][]Instruments verification
[][]Utility Verification
[][]Deviation and Failure Investigation Summary

Conclusion

[][]The Installation Qualification of Laminar Air Flow Unit of Cephalosporin Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained have been filled up in the respective table of each test.
[][]The Laminar Air Flow Unit of Cephalosporin Block is / is not qualifying the Installation Qualification test as per this Protocol. Hence, the system can be / cannot be used for Operational Qualification.

Download Here

Laminar Air Flow Installation Qualification

Laminar Air Flow Installation Qualification Read More »

Air Compressor Performance Qualification

Performance Qualification Protocol, Pharma Operations, Protocol

Purpose

To determine that the oil free air compressor performs as per the given specifications, by running the system on its intended schedules and recording all relevant data under normal conditions & for worst-case situations where applicable.

Scope

This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on the oil free air compressor systems, comprising of compressor, drying system, filtering system, piping, control system etc. installed in General Block of XX Pharmaceuticals Ltd. The scope will include measuring oil content, dew point test, particulate contamination and microbial count of compressed air system.

People Also Read

Compressed Air Operational Qualification

Responsibilities

[][]Preparation of the protocol
=>Validation (Engineering) Department with the assistance of Microbiology, Quality Assurance and Engineering department.
[][]Executing the protocol
=>Validation team along with respective departmental person and engineers or other suitably qualified staffs allocated from the site or contracted specialists as appropriate.
[][]Oil and dew point test
=>Validation (Engineering) Department
[][]Microbiological Test
=>Microbiology Department
[][]Data documentation and preparation of the report
=>Validation (Engineering) department.
[][]Verifying of the report
=>Concerned departmental person.
[][]Providing documentation on the equipment
=>Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.

System and process description

system information
=>Manufacturer : Atlas copco
=>Capacity : 10.4 m3/hr
=>Model : Zt-75
=>Serial no. : Apf166068

The System under test

[][]The Atlas Copco Air Compressor manufactured by Atlas Copco has a capacity of 10.4 m3/min. Air drawn through an air filter, is compressed in low-pressure compressor element and discharged to the intercooler.

[][]The cooled air is further compressed in high-pressure compressor element and discharged through silencer and after coolers. A check valve is provided downstream of the silencer.

[][]The compressed air leaves the compressor via the air outlet. The compressor delivers oil-free, pulsation-free air.
[][]This is an air cooled type compressor which is facilitated with air filter, moisture trap, high pressure and low pressure safety valve, desiccant type dryer system etc.
[][]After being compressed in compressor the oil free compressed air will be stored in a receiver tank. There are two desiccant type air dryers. Air is dried in the air dryers and then distributed through pipe line to the different facility.

Performance Tests

The tests for performance qualification of compressed air as follows:
#Oil content Test Method
[][]Ensure that the compressed air is supplied at a pressure between 2.8 – 3.2 bar.

[][]Connect the sampling point at the port of 10 bar of the pressure reducer of Drager Aerotest Simultan HP.

[][]After that, connect the measuring device with the pressure reducer and insert an oil impactor kit of Drager Aerotest Simultan HP into the oil testing port of the measuring device.

[][]Open the compressed air valve and collect the sample for 5 minutes. The time is counted by a calibrated timer.

[][]Finally, check the oil impactor kit if there is any spot on the screen. The following figures will be used to measure the quantity of the oil:

[][]Perform the test for 3 consecutive working days.
[][]Record the result in Appendix 1.

Acceptance Criteria

=>The compressed air should meet the specification of ISO 8573-1:2010 class 0. Hence, the compressed air must contain no oil.

Dew point test

Test Method
[][]Ensure that the compressed air is supplied at a pressure between 2.8 – 3.2 bar.

[][]Connect the sampling point at the port of 10 bar of the pressure reducer of Drager Aerotest Simultan HP.

[][]Break the both tips of a Water Content Test Kit. After that, connect the measuring device with the pressure reducer and insert a kit into the H2O testing port of the measuring device.

[][]Open the compressed air valve and collect the sample for 10 minutes.

[][]The time is counted by a calibrated timer. The color of the kit will be gradually changed from yellow to red.

[][]The reading is marked on the body of the kit. Get the reading up to which the color is changed.

[][]Calculate the dew point using the table provided in Appendix 06. Perform the test for 3 consecutive working days.
Record the result in Appendix 1.

#Acceptance Criteria
=>The compressed air should meet the specification of ISO 8573-1: 2010 class 2. Hence, the dew point of the compressed air must be equal to or less than – 400C.

Particulate contamination

Test Method

[][]Connect the sampling point with the High Pressure Diffuser and open the valve of compressed air to flush the line. After that, connect the other end of the High Pressure Diffuser with the air borne particle counter and commence particle counting for 0.5 micron and 5.0 micron particles.

[][]The sample collection time will depend on the room grade of the user point of compressed air.

[][]For example, if the user point is located in a Grade-D area, the sample will be collected for 1 minute. Please see the table of section for sample collection time for each grade.
[][]Perform the test for 3 consecutive working days.
[][]Record the results in the result sheet in Appendix 3.

#Acceptance Criteria

=>The specifications will differ according to the room classification, which are given below:

Maximum Permitted Number of Particles/m3

Room Class	0.5mic.m	5mic.m
A	3520	20
B	3520	29
C	352000	2900
D	3520000	29000

Microbial Count

Test Method

[][]The test will be performed according to the SOP No.: SOP/YY/XX where XX is the current revision of the SOP.
[][]Perform the test for 3 consecutive working days.
[][]Record the results in the result sheet in Appendix 4.

#Acceptance Criteria:

=>The specifications of this test according to the different room classifications are given below:

Room Class	Acceptance Limit CFU/m3
Grade A	<1
Grade B	10
Grade C	100
Grade D	200

Sterility Test

Test Method
[][]This test will be performed only for ACSP – 03. The test will be performed according to the SOP No.: SOP, where XX is the current revision of the SOP.
[][]Perform the test for 3 consecutive working days. Record the results in the result sheet in Appendix 4.

#Acceptance Criteria:

=>The air at this point must be sterile.

Sampling Points and Test Frequency

[][]The list of sampling points which come into product contact is given below:

Sl. No.	Room Name	Tests	Frequency
01	Post Staging	Oil content, dew point, and particle count, microbial count	1 year
02	Washing and Sterilization room	Oil Content, Dew point and particle count, microbial count	1 year
03	Vial Filling room	Oil content, dew point, particle count and Sterility test	1 year

Deviation And Failure Investigation Summary

=>In the column below, record any deviation or failure that occurred during the PQ exercise.

Reference Documents

=>ISO 8573-1:2010: Air Quality Classes.

Conclusion

[][]The Performance Qualification of Atlas Copco Air Compressor of General Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained are attached with the protocol.
[][]The Atlas Copco Air Compressor is / is not qualifying the Performance Qualification test as per this Protocol. Hence, the system can be / cannot be used for production operation.

Download Here

Air Compressor Performance Qualification Protocol

Air Compressor Performance Qualification Read More »

Air Compressor Operational Qualification

Protocol

Air Compressor Operational Qualification , Purpose

Air Compressor Operational Qualification , To verify and document that the oil free air compressor system operates as designed and intended. The operational parameters should be consistent with the requirements for the Manufacturing process. The OQ is aimed to verify that the installed equipment performs according to the manufacturer’s specifications.

Air Compressor Operational Qualification , Scope

This Operational Qualification (OQ) is to be performed against agreed acceptance criteria on the air compressor systems, comprising of compressor, drying system, filtering system, piping, control system etc. installed in the General Block of XX Pharmaceuticals Ltd. The scope will include assessment of equipment design and installation, connection to utilities, presence & function of instruments.
The scope will include the operational testing of the normal sequence of operation and verification of the target limits of operation.

People Also Read

Air Compressor Installation Qualification

Responsibility

[][]Preparation of protocol
=>Engineering Department.
[][]Executing the protocol
=>Engineering department or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Providing documentation on the equipment
=>Related departments i.e. engineering Production, Validation or other appropriate departments and manufacturer.
[][]Data documentation and preparation of the report
=>Raw data documentation is the responsibility of those conducting the validation. Preparation of the report and incorporation of data will be the responsibility of the Engineering Department.

Background

Project Description & Related issues
[][]This air compressor system is installed to serve General and Cephalosporin Block. To meet the demand of quality of compressed air, this oil free air compressor has been installed.

Purchasing Information

Item	Brand	Model	Origin
Air Compressor	Atlas Copco	ZT 75	Belgium
Dryer	Atlas Copco	CD185+	Belgium
Air receiver	Atlas Copco	NA	Germany
Piping and distribution	Fabricated	N/A	Local

System Description

[][]The Atlas Copco Air Compressor and Air Dryer manufactured by Atlas Copco has a capacity of 10.4 m3/min. Air drawn through an air filter is compressed in low-pressure compressor element and discharged to the intercooler.

[][]The cooled air is further compressed in high-pressure compressor element and discharged through silencer and after coolers.

[][]A check valve is provided downstream of the silencer. The compressed air leaves the compressor via the air outlet. The compressor delivers oil-free, pulsation-free air.
This is an air cooled type compressor which is facilitated with air filter, moisture trap, high pressure and low pressure safety valve, desiccant type dryer system etc.

Following parameter shall be perform at the time of Operational Qualification

[][]Verification of completion of sops
[][]Verification of training
[][]Operational testing
[][]Instrument calibration
[][]Deviation and failure investigation summary
[][]Report summary

Conclusion

The Operational Qualification of Compressed Air System installed at General Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained are attached with the protocol.
The Compressed Air System is / is not qualifying the Operational Qualification test as per this Protocol. Hence, the system can be / cannot be used for Performance Qualification.

Download Here

Air Compressor Operational Qualification Protocol

Air Compressor Operational Qualification Read More »

Air Compressor Installation Qualification Protocol

Protocol

Air Compressor Installation Qualification, Purpose

Air Compressor Installation Qualification, To verify and document that the oil free air compressor systems are designed, built and installed according to the XX Pharmaceuticals Ltd. demand and manufacturer specifications and documentation is compiled to verify the integrity of the installation.
This should result in acceptable documented evidence that the oil free air compressor system have been correctly installed in compliance with specification. This new IQ protocol will focus both the General and Cephalosporin Block.

Air Compressor Installation Qualification, Scope

This Installation Qualification (IQ) is to be performed against agreed acceptance criteria on the air compressor systems, comprising of compressor, drying system, filtering system, piping, control system etc. installed in the General Manufacturing area at the XX Pharmaceuticals Ltd. The scope will include assessment of equipment design and installation, connection to utilities, presence & function of instruments.

People Also Read

HVAC Operational Qualification

Responsibilities

[][]Preparation of protocol
=>Engineering Department
[][]Executing the protocol
=>Engineering department or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Providing documentation on the equipment
=>Related departments i.e. Engineering, Validation or other appropriate departments and manufacturer
[][]Data documentation and preparation of the report
=>Raw data documentation is the responsibility of those conducting the validation. Preparation of the report and incorporation of data will be the
=>responsibility of the Engineering Department.

Background

[][]Project Description & Related issues
[][]This air compressor system is installed to serve Cephalosporin and General Block. To meet the demand of quality compressed air this oil free air compressor will be installed.

Purchasing Information

Item	Brand	Model	Origin
Air Compressor	Atlas Copco	ZT 75	Belgium
Dryer	Atlas Copco	CD 185+	Belgium
Air receiving tank	Atlas Copco	N/A	Germany
Piping and distribution	Fabricated	N/A	Local

System Description

[][]The cooled air is further compressed in high-pressure compressor element and discharged through silencer and after coolers. A check valve is provided downstream of the silencer.

[][]Air will be dried in the desiccant type dryer and then distributed through pipe line to the different production facility.

Verification Of Installation

Drawings

[][]Physical installation of all the Compressed air related work has to be verified against reference drawings.

[][]The installations that will be found identical with the drawings will be marked by green color and those which will not match with the drawings will be marked by red/orange color.

Drawing Details	Drawing Title	Drawing Number	Drawing Change Required Yes/No	Initial with Date
Distribution of Compressed Air in Cephalosporin and General Block	Distribution of Compressed Air in Cephalosporin and General Block
Airflow Schematics	Air flow schematic Drawing for Atlas copco Air Compressor
Air Compressor Floor Plan drawing	General Building Roof Top
Electrical Work	Electrical diagram

Item Wise Verification

1.0 Air Compressor

2.0 Desiccant Dryer

3.0 Air Filter

4.0 Air Reservoir

5.0 General Installation Checking

6.0 Instrumentation

7.0 Utilities

All of the parameter has been depicted on assigned protocol.

Deviation And Failure Investigation Summary

In the column below, record any deviations or failures that occurred during the IQ exercise.

Report summary

The report summary of installation qualification of atlas copco air compressor of general block is as as described.

Conclusion

[][]The Installation Qualification of Atlas Copco Air Compressor installed at General Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained are attached with the protocol.
[][]The Atlas Copco Air Compressor of General Block is / is not qualifying the Installation Qualification test as per this Protocol. Hence, the system can be / cannot be used for Operational Qualification.

Download Here

Compressed Air Installation Qualification Protocol

Air Compressor Installation Qualification Protocol Read More »