Mr. Prasad I am not satisfied with minimum requirement of class 10000 for optical Inspection as you mentioned. And non where it is mentioned that flip off seal must be sterilized for sealing.
[quote=DURGA PRASAD]MANDATORY GMP’s are:
Special change room for entry and Exit, Vials are loaded on to machine under a LAF CLASS100, Operators must wear Gloves & masks, Make sure that you wash vials with DM & Water for injection at 3 bar pressure.The WFI should be filtered thru a Sterilizing grade membrane, DM should be thru 10 micron and 5 micron filter(the DM return water too) Air should be thru a sterilizing grade membrane and the whole area should be under class 10000 area. The Unloading side should have a LAF class 100.
TUNNEL PRE HEATING ZONE: Make sure that it is under class 100 LAF,always keep an eye on the vial over loading switch, make sure that conveyer runs with a predetermined speed that is obtained from Validation report or speed limit set for that particular vial.
TUNNEL HEATING ZONE FOR DEYROGENATION : Make sure that vial residence time should be properly maintained, All the heating is recorded on to the PLC and printed along with Batch Number, Time, Date & Batch Name and Operators name.
TUNNEL COOLING ZONE: Make sure that you clean this cooling tunnel conveyer with IPA 70% to reduce the contamination. Make sure that you disinfect this area and take repeated bacterial counts. This is a critical area and should be maintained like class 100. The Depyrogenated vials are exposed here for cooling and might get contaminated with dust or microbes. Make sure that the assurance is not compromised. The Airvelocity should be here atleast 1500CFM and always make sure that air velocity at Class 100 is more and Air passes from Class 100 into Tunnel cooling zone but not vise versa. DO NOT OPEN THIS AND TOUCH VIALS–IF YOU OPEN THIS ZONE VIALS SHOULD NOT BE USED FOR MANUFACTURING.
VIAL ENTERS CLASS 100 AREA UNDER LAF ON TO A TURN TABLE- Strict Microbial controls at this area.
VIAL IS PURGED WITH NITROGEN GAS: Vials are purged with N2 gas so that the oxygen in air will be displaced. Nitrogen comes thru a sterilizing grade filter. Carry out Microbial limits at this point and in Nitrogen from Time to time. This has very tight Sterility Assurance Limits(SAL)- THIS AREA IS UNDER CLASS 100 LAF OR CLASS 100 AREA OR CLASS 100 LAF BACKGROUND CLASS IS 1000. LATEST GMP NEVER ALLOWS CLASS 10000 AT THIS AREA AS BACK GROWND.
VIAL IS FILLED WITH STERILE POWDER: Strict Microbial controls, The Area should be 20-22C temerature, Relative Himidity 35%-40%, CLass 100, The whole Filling Set should be Soiliconised,presterilised & dried to remove moisture or water. Should be operated with proper care. The Product dispensing CHUTE must be aligned with proper care with out leaks and all equipments in this zone are Siliconised.
VIAL IS BUNGED OR PLUGGED; Rubber bungs must be sterilized, Siliconised & Dried. Entire operation is under CLASS 100 AREA. NO CONTACT OF STOPPERS WITH HANDS, NO STOPPER-VIALS ARE REJECTED.
TURN TABLE: STRICT CLASS 100, NO CONTACT WITH ANY PERSONNEL, STRICT STERILITY ASSURANCE FOR VIALS CLOSED WITH STOPPERS, ANY VIALS WITH OUT STOPPERS MUST BE REJECTED MANUALLY IF THERE IS NO AUTOMATIC SYSTEM ON THE CONVEYER TO TURN TABLE.
VIAL GOES ON CONVEYER TO CAPPING HEAD–VIALS ARE CAPPED WITH FLIP OFF SEALS -CLASS 100 LAF, THE FLIP OFF CAPS MUST BE STERILISED-
VIALS COME OUT
VIALS ARE INSPECTED --OPTICAL INSPECTION FOR WEIGHTS & PARTICULATES AND VIAL NON CONFIRMITIES- CLASS 10000 AREA
VAILS ARE QUARENTINED- Very tight control under quarentine, Seggregate the rejected vails and allow not to mixup with the good vials. Lable them properly with Date, Btach number, Batch size, Number of Vials in each Tub or Pallet or Container, Date of visual inspection -sign of operator, supervisor & QA incharge.LOCK AND KEY ARE MUST HERE.
DO NOT DARE TO REMOVE THE REJECTED MATERIAL AND US FOR REPROCESSING. AFTER CERTAIN TIME QA MUST STRICTLY THEM THE REJECTS UNDER THEIR CONTROL AND POUND ALL VIALS AND SHOW THEM IN RECONCILLIATION STATEMENT.
AFTER 14 DAYS QC GIVES REPORTS
LABLE & DISPATCH
Points for strict implementation:
ENTRY EXIT PROCEDURES
STRICT MICROBIAL CONTROLS
GOWING QUALIFICATION AND PROCEDURES
REGULAR MICROBIAL MONITORING FOR MATERIALS, PROCESSES, ENVIRONMENT AND PERSONNEL IN CRITICAL AREAS AND SUPPORTING AREAS AND DIRECT CONTACT UTILITIES LIKE WATER FOR INJECTION, AIR, NITROGEN ETC.
NO DEVIATION FROM CONTROLS OR LIMITS.
IF DEVIATION IS OBSERVED BATCH MUST BE QURENTINED AND STRICT STERILITY ASSURANCE TESTING PROCEDURES MUST BE ESTABLISHED AND CAUSE OF DEVIATION MUST BE IDENTIFIED AND IF STAFF COMMITS THAT THEY MUST BE WARNED.
NO COMPROMISE POLOCY : STERILE AREA, EQUIPMENT CLEANING, EQUIPMENT DECONTAMINATION, DISPENSING SYSTEMS, PERSONNEL MOVEMENT -CLEANLINESS, DOCUMENTATION, MICROBIAL CONTROLS AND OTHER SPECIFIED CONTROLS.[/quote]