Technology

Sterile Production

Starting from the design and construction of facility, in facility design, Air locks are provided for the physical separation of different stages of changing and to allow proper movement of personnel, material and equipment etc. between different environmental zones. Lockers are provided for safe storage of personal items, clothing, for the storage of clean/sterile garments, hand washing (pre change only) and disinfecting facilities etc. Separate airlocks for personnel entering and leaving the Class A/B (ISO 5) areas are provided. Doors of airlocks are fitted with an interlocking system to prevent opening of the exit/entry doors at the same time. The HVAC systems is designed to controlled with a Building Management system (BMS Indirect system), Critical items (product/facility related) will be monitored and recorded using an Environmental Monitoring System (fully validatable) and connected with alarm system on a standalone direct impact system (EMS Direct impact system).This system is designed to link to the security gate house for alarm response action.

The differential air pressure between rooms of different classification is designed between 10-15 Pascal. The filling of vials, movement of filled vials to the lyophilizer, loading /unloading and capping is designed to perform under Class A (ISO Grade 5) with Laminar air Flow, within a Class B (ISO Grade B) background. The filled sealed vials will be leak tested using suitable validated equipment. The standards are kept for all other sterile filling including, cartridges, ampoules and pre-filled syringes.

Adequate warehousing is designed to provide the storage of raw materials and components at their required storage conditions, with segregation of quarantine and released materials. Appropriate Storage for API’s (under controlled temperature) within the storage area is considered in design. Separate, secure and dedicated storage facilities for labeling materials are also considered. Separate and dedicated storage facility is designed for rejected materials; this will be located within the warehouse area such that removal of any rejected materials will not require passage through the warehouse. Cold room (2-8ºC) storage for finished products is designed within the finished goods area. Water for Injection (WFI) will be produced from PW by multi-effect distillation or Thermo compressor system, the WFI will be the source water for the generation of Clean Steam (CS).The WFI multi-effect distillation or Thermo compressor system and CS generator will be manufactured according to current GAMP and USP requirements for the production and storage of Water for Injection. Water For Injection will be stored at a temperature ≥۷۰ºC in a sterilisable, 0.22μm filet vented, 316L stainless steel heated storage tank of suitably capacity. Stored water will be maintained under continuous circulation through 316L Stainless steel distribution loops to the required outlets and service take offs. The SS piping will be continuous were possible, using orbital argon arc welding. Aseptic fittings and seals will be kept to a minimum. WFI will be circulated at a temperature ≥۷۰ºC. Consideration shall be given to future equipment and processes. UPS system is designed to maintain the electrical supply to critical areas and equipment in event of external mains failure until the emergency electrical generator system is fully running, a controlled switch over will also be used when the main electrical supply has been restored. The principle equipment including vial/cartridges washer, sterilizing/de-pyrogenation, filling and capping, autoclaves, lyophilizer, syringe filling, leak testing, complete ampoule and prefilled syringes production lines etc., will be supplied by leading manufacturers according to the GAMP requirements and guidelines.

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