Amendment status not verified — confirm the current text below against the official source.
Parenteral Preparations The whole operation of manufacture of parenteral preparations (small volume injectables and large volume parenterals) in glass and plastic containers may be divided into the following separate areas/rooms, namely: - 11.1 Parenteral preparations in glass containers: – (1) Water management area: This includes water treatment and storage. (2) Containers and closures preparation area: This includes washing and drying of ampoules, vials, bottles and closures. (3) Solution preparation area: This includes preparation and filtration of solution. (4) Filling, capping and sealing area: This includes filling and sealing of ampoules and/or filling, capping and sealing of vials and bottles. (5) Sterilization area (6) Quarantine area (7) Visual inspection area. (8) Packaging area Drugs and Cosmetics Rules, 1945 434 The following equipment is recommended for different above-mentioned areas, namely: - (a) Water management area: (1) De-ionised water treatment unit. (2) Distillation (multi-column with heat exchangers) unit. (3) Thermostatically controlled water storage tank. (4) Transfer pumps. (5) Stainless steel service lines for carrying water into user areas. (b) Containers and closures preparation area: (1) Automatic rotary ampoule/vial/bottle washing machine having separate air, water distilled water jets. (2) Automatic closures washing machine, (3) Storage equipment for ampoules, vials, bottles and closures. (4) Dryer/sterilizer (double ended) (5) Dust proof storage cabinets. (6) Stainless steel benches/stools. (c) Solution preparation area: (1) Solution preparation and mixing stainless steel tanks and other containers. (2) Portable stirrer. (3) Filtration equipment with cartridge and membrane filters/bacteriological filters. (4) Transfer pumps. (5) Stainless steel benches/stools (d) Filling, capping and sealing area: (1) Automatic ampoule/vial/bottle filling, sealing and capping machine under laminar air flow workstation. (2) Gas lines (Nitrogen, Oxygen, Carbon dioxide) wherever required. (3) Stainless steel benches / stools. (e) Sterilization area: (1) Steam sterilizer (preferably with computer control for sterilization cycle along with trolley sets for loading/unloading containers before and after sterilization). (2) Hot air sterilizer (preferably double ended). (3) Pressure leak test apparatus. (f) Quarantine area. – (1) Storage cabinets. (2) Raised platforms/steel racks. (g) Visual inspection area: (1) Visual inspection units (preferably conveyor belt type and composite white and black assembly supported with illumination). (2) Stainless steel benches/stools. (h) Packaging area. - (1) Batch coding machine (preferably automatic). Drugs and Cosmetics Rules, 1945 435 (2) Labelling unit (preferably conveyor belt type). (3) Benches/stools. Area. – (1) A minimum area of one hundred and fifty square meters for the basic installation and an Ancillary area of one hundred square meters for Small Volume Injectables is recommended. For Large Volume Parenterals, an area of one hundred and fifty square meters each for the basic installation and for Ancillary area is recommended. These areas shall be partitioned into suitable enclosures with airlock arrangements. (2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mix up. (3) Packaging materials for large volume parenteral shall have a minimum area of 100 square meters. 1[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.] 11.2 Parenteral preparations in plastic containers by Form-Fill-Seal/Blow, Fill- Seal Technology.-The whole operation of manufacture of large volume parenteral preparations in plastic containers including plastic pouches by automatic (all operations in one station) Form-Fill-Seal machine or by semi-automatic blow moulding, filling-cum-sealing machine may be divided into following separate areas/rooms, namely: - (1) Water management area. (2) Solution preparation area. (3) Containers moulding-cum-filling and sealing area. (4) Sterilization area. (5) Quarantine area . (6) Visual inspection area. (7) Packaging area. The following equipment is recommended for different above mentioned areas namely: - (a) Water management area: (1) De-ionised water treatment unit. (2) Distillation unit (multi column with heat exchangers). (3) Thermostatically controlled water storage tank. (4) Transfer pumps. (5) Stainless steel service lines for carrying water into user areas. (b) Solution preparation area: (1) Solution preparation and storage tanks. (2) Transfer pumps. (3) Cartridge and membrane filters. (c) Container moulding-cum-filling and sealing area: (1) Sterile Form-Fill-Seal machine (all operations in one station with built-in laminar air flow workstation having integrated container output conveyor belt through pass box). (2) Arrangement for feeding plastic granules through feeding-cum-filling tank into the machine. ________________________________________________________________________