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.
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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.
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Vial washing Machine Performance Qualification Protocol