Wash Water, Purpose:
Wash Water, The purpose of this SOP (Standard Operating Procedure) is to define the Sampling and analytical procedure for wash water.
Wash Water, Scope:
This procedure is applicable for sampling of wash water from production equipments and analysis of wash water in the Quality Control laboratory of XX Pharmaceuticals Ltd.
Definition:
None
Responsibilities:
The roles and responsibility is as follows:
Executive, Production
[][]To co-ordinate to collect the sample as per defined procedure
[][]To send duly filled Wash Water Sampling Advice Form to QC/QA Department.
[][]To maintain the proper documentation.
Sr. Executive/Executive, Quality Assurance
[][]To withdraw the sample as per the defined procedure.
Sr. Executive/Executive, QC
[][]To analyze the sample as per defined procedure
[][]To ensure that this procedure is kept up to date.
Manager, Quality Control
[][]To ensure appropriate personnel from the section are trained on this procedure.
[][]To confirm that SOP is technically sound and reflects the required working practices.
Head of Quality Assurance
[][]To ensure the overall implementation of the SOP.
[][]Approval of the SOP.
Procedure:
[][]Production personnel clean the equipment as per standard cleaning procedure, intimates QC/QA for wash water sampling with the “Wash Water Sampling Advice Form” in duplicate.
[][]Quality Compliance representative inspects the equipment and its parts for cleanliness and then collects the sample as follows:
Vibratory Shifter:
[][]Attach the sieve on the body of the sifter and wash with 3.0 L of Purified water and collect the sample at the receiver into a clean bowl. Rinse the dismantled parts (Lid, clamp, hopper and silicon gasket) with 2 liters of purified water and collect into the same bowl. Collect approx. 30 ml of the sample into an amber colored bottle for analysis.
Container Blender:
[][]Rinse the colloid mill with 3.0 L of Purified water and collect it into a clean bowl. Collect 30ml of the sample into an amber colored bottle from the bowl for analysis.
Rapid Mixer Granulator:
[][]Rinse the equipment bowl and top lid with 30.0L of Purified water and collect the water into a clean bowl through the discharge taking care that the whole surface of the bowl and top lid is rinsed properly and rinse the dismantled parts (clamp for binder addition, charging port, spray nozzle, vent filter, chopper blade, impeller blade discharge valve and all gaskets) with 5 liters of purified water and collect into the same bowl. Collect approximately 30 ml of sample into an amber colored bottle for analysis.
FBD (Fluid Bed Drier):
[][]Rinse the retarding chamber internally with 10.0 L of Purified water and collect it into a clean bowl. Collect approximately 30 ml of the sample into an amber colored bottle for analysis. Similarly rinse the FBD trolleys with 10.0 L of Purified water each and collect 30ml of the sample separately from the two bowls. Rinse the cartridge filters/FBD bag with 5-liters of purified water and collect the water into the clean bowl. Collect approximately 30 ml of the sample into an amber colored bottle for analysis.
Tablet Coating Machine:
[][]Rinse the pan with 10.0L of Purified water and collect the sample into a clean bowl through the discharge taking care that the whole surface and the Baffles are rinsed properly. Rinse the dismantled parts (Silicon tube, Gun assembly, inlet duct and outlet duct) with 5 liters of purified water and collect into the same bowl. Collect approximately 30 ml of the sample into an amber colored bottle for analysis.
Compression machine:
[][]Rinse the hoppers, butterfly valve, triclover clamp, force feeder, inlet connector, Turret guards, Powder scrapper, Acrylic guards, feeder shaft, Exhaust pipes with 5 liters of purified water and collect in a clean bowl. Collect approximately 30 ml of this sample into an amber colored bottle for analysis. Similarly rinse the y – chute, Gravity pipe with 5 liters of purified water and collect in the clean bowl. Collect approximately 30 ml of this sample into an amber colored bottle for analysis.
Capsule Filling Machine:
[][]Rinse the capsule loading channel, hopper, Loading ring, Auger, Locking pin assembly with 5 liters of purified water and collect in to clean bowl. Collect approximately 30 ml of this sample into an amber colored bottle for analysis.
Capsule polishing Machine:
[][]Rinse S.S cover of polishing Machine and polishing brush with 2 liters of purified water and collect in to clean bowl. Collect approximately 30 ml of this sample into an amber colored bottle for analysis.
[][]While collecting wash water sample, collect Purified water about 30 ml into an amber colored bottle.
[][]Use this as blank.
Note: For the equipments, which are not specified above, use 2.0 L, 5.0 L, & 10.0 L as the rinsing water quantity depending on the size i.e. small, medium & big.
Analysis:
[][]After getting sampling advice form from production department, QC personnel will entry in the wash water register and assign a lab control number as WW-000X/MM/XX(where WW for Wash Water, 000X- Sequential number of four digits, MM-Month and YY-Last two digits of year. For example: WW-0001/08/XX). Then the compliance personnel will collect the sample and send to Quality Control department for analysis.
[][]QC analyses the sample by scanning through 190-400 nm on UV-VIS Spectrophotometer, using Purified water (collected as explained earlier) as blank.
[][]Observe for any abnormal peaks and/or peaks having same wavelength maximum of active material of previous product.
[][]Reject the sample in case of any abnormal peak or if a peak of previous product having more absorbance that of a 10 ppm standard solution of active of previous product and send the information to the concerned department.
[][]Take the spectrum print out on the back side of the wash water report copy (QC copy) and inform production for rewash.
[][]If absorbance is less than that observed in standard graph, intimate the concerned department by sending the original copy of the report after making necessary entries and approving the clean card. Retain the duplicate copy of the report and file it after making necessary entries in the register.
Annexure:
Annexure-I: Wash Water Sampling Advice Form.
Annexure-II: Wash Water Register.