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Cleaning of reactor After using reactor update status board to be clean and date, Close the bottom valve

om valve of reactor or Ensure bottom valve of reactor close or not, A water fill in the reactor and clean it or to be clean with water reflux at 80 to 90C, and drain water. After to be clean reactor with methanol reflux. or flush methanol in the reactor. Apply steam in reactor jacket at 40 C and dry the reactor. Ensure reactor clean or not. And verify with other person. Other wise to clean reactor with methanol reflux. If reactor is clean then change status board cleaned or ready for use

Operation of reactor Check reactor is clean and verify with other person. Close the bottom valve of reactor or Ensure bottom valve of reactor its in close condition or not, Ensure reactor temperature and all system is proper working condition. To update status board of reactor with batch number and date. After Start procedure as per BMR/PRC. All solid material to charge with SCOOP in the reactor. After charging a material properly fit manhole of reactor. After using reactor update status board to be clean. Cleaning of multi mill After using multi mill update status board to be clean and date, Open multi mill basket and sieve. To clean multi mill with water and flush all part with methanol. To dry all multi mill part and to check its proper clean or not. Ensure multi mill sieve its not broken then fit all parts. After to change status board cleaned or ready for use

Operation of multi mill Check multi mill is clean and verify with other person. Ensure multi mill sieve and basket is proper fit. Update status board of multi mill with batch number and date. After start multi mill and check is proper working. Start multi milling as on procedure. Charge material with scoop. Collect material in inprocess drum with single plastic bag. After using multi mill to open and ensure sieve is damage or ok.

After using multi mill update status board to be clean.

Cleaning of centrifuge After using centrifuge update status board to be clean. Remove centrifuge bag and clean with water. To clean centrifuge with water and moping with methanol. After to flush water in centrifuge and clean all holes of CF. After To dry centrifuge bag and to check its not broken or pin hole observe then fit. If pin hole or any broken part observe in centrifuge bag to replace with new bag and fit. Ensure centrifuge And verify with other person. After change status board cleaned or ready for use

Operation of centrifuge First to check centrifuge is clean and verify with other person. Check Centrifuge bag is clean then to fit proper. Before use to check centrifuge bag is not broken or any pin hole observe. If pin hole or any broken part observe in centrifuge bag to inform authorize person. Update status board data and start process as per BMR/PRC. After centrifuging remove material with Scoop and collect in inprocess drum with single plastic bag. After used centrifuge to be clean or update a status to be clean.

Cleaning of tray dryer After using tray dryer update status board to be clean. Remove all tray and tray dryer clean with water. To clean all tray with water and moping with methanol. After all tray to fit in dryer and apply steam at 40 C and dyr. Ensure dryer clean or not. And verify with other person. After cleaning tray dryer to change status board cleaned or ready for use

Operation of tray dryer First to check tray dryer system is working proper. Ensure all tray is clean and verify. Charge material in tray with butter paper.

Set temperature range as per BMR/PRC. All tray to fin in dryer and start as per BMR. After use tray dryer to clean with all tray.

Area cleaning Clean a floor, windows and all area are twice in day. Clean area with savlon + water solution. Clean all door and door gaps. Clean all glass with 70% IPA solution. In production area to do fogging with 5% dettol solution. Plant surrounding areas to keep maintain or clean. All equipment to clean from outside with dry cloth or duster.

Final packing of material First to check batch number and verify with QC Lab material is approved then transfer material in packing area. Clean required drum and plastic bag for final packing. Check weight balance calibration or calibrate with standard weight. Check tare weight of drum with plastic bag and set zero on balance. After start to transfer material in( 25kg,50kg, or as per party requirement wt) plastic drum with clean and dry scoop. After all material transfer in drum then re weight material and verify tare wt, Net wt and Gross wt. After to pack material in plastic bag with strip. After clean all drum and transfer with approved Final material area or to be applying label for dispatch.

Raw material store Raw material area to keep clean or dry. Daily note a room temperature in store area. Keep all material separately or maintain distance between to material. Note daily stock of approved or under test material. Keep to be sample material separate and to send request in QC for analysis. After QC sampling material to keep in under test area. After by QC analysis report is approved then keep with material in approve area or in use.

If analytical report is fail then material to keep a side and apply label DONT USE All material to specify with approved/under test label.

Balance cleaning or calibrating Daily to clean weight balance and standard weight with duster or dry cloth Check weight balance is working properly or out off calibrated. Keep standard weight of 1kg, 10kg, 50kg, 100kg on weight balance and check calibration as per following chart.

Standard weight in kg
1 10 50 100 .

Maximum error in kg
1.001 10.01 50.05 100.10

Minimum error in kg
0.99 9.99 49.95 99.90

If weight Balance is not working properly or out of calibration (out of range) inform to authorize person. Set 0 (zero) on the screen of weight balance after or before to use. Before any material to weight check tare weight or set tare weight 0 (zero) then weight proper. After using weight balance to be clean with dry cloth and off.

Equipment logbook

Training file for worker Temperature record

Raw material AR report book Final material AR report book In process AR report book

In process Sample register

Sampling register Coa of rm Coa of product Material Repacking file Fos BMR Rinse and swab test record

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