Preventive action: The manufacturer shall determine action to eliminate the causes of potential non-conformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for-— (a) determining potential non-conformities and their causes, (b) evaluating the need for action to prevent occurrence of nonconformities, (c) determining and implementing action needed, (d) recording of the results of any investigations and of action taken, and (e) reviewing preventive action taken and its effectiveness. ANNEXURE'A' [Refer sub-paragraph 6.4(b)] ENVIRONMENTAL REQUIREMENT FOR MEDICAL DEVICES AND IN VITRO DIAGNOSTIC MEDICAL DEVICES Name of Device Type of Operation ISO Class(At rest) Cardiac Stent / Drug Eluting Stent Primary Packing and Crimping 5 Washing, Ultrasonic cleaning & Drug coating 7 Assembly, Wrapping and Packaging 8 Laser cutting, Descaling, Annealing and Electro polishing 9 Heart Valves Valve Packing 5 Ultrasonic Cleaning and Visual Inspection 7 Frame and Disc Assembly 7 Intra Ocular Lenses Primary Packing and Sealing 5 Final Inspection 7 Power Checking and Final Cleaning 8 Tumble Polishing and Lathe Cutting 9 Bone Cements Final Product Filling 5 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 159 of 248 Sieving and Calcinations 7 Powder Preparation, Granulation and Drying 8 Internal Prosthetic Replacement Primary Packing 5 Product Preparation 7 Component Preparation 8 Orthopaedic Implants Cleaning and packaging (to be sterilized in factory premises) 7 Cleaning and packaging (Non Sterile to be sterilized in Hospital) 8 Cutting, Lathing, and Polishing 9 Catheters / Ablation Device / IV Cannulae/Scalp Vein Set/ Hypodermic Syringes / Hypodermic Needles / Perfusion Sets Assembly, Coating, Wrapping and Packing 7 Component Preparation and Cleaning 8 Moulding 9 49[Condoms Compounding Well ventilated area with neat and clean environment, free from dust and other particulate matter Moulding Well ventilated area with neat and clean environment, free from dust and other particulate matter Vulcanising Normal Air Primary Packing Air Conditioned] Intra Uterine Devices Moulding Well ventilated Area with minimum 5 micron filter Assembling 7 Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 160 of 248 Primary Packaging 7 Tubal ring Extrusion 7 Cutting and Assembly 7 Primary Packaging 7 Blood bags Moulding / Extrusion of components 8 Assembly 7 Filing 5 Suture Extrusion 9 Assembly 8 Primary Packing 8 Staplers Staple formation 9 Staple assembly 8 Staple Primary pack 8 Ligatures Extrusion 9 Cutting and assembly 8 Final Primary Packing 8 50 [Sterile surgical dressings Final Primary Packing 9] In vitro diagnostic medical devices (Kit/Reagents) Dry, Liquid Reagent Preparation Well Lighted and Ventilated controlled temperature & humidity as per process or product requirement Coating of sheets etc. Assembly and primary packing Filling Well Lighted and Ventilated controlled temperature and humidity as per process or product requirement. Provision of Laminar hood if required, Clean Room class 8 or class 9 as per product/ process requirement Secondary Packing Well lighted and ventilated controlled Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 161 of 248 temperature if required. Storage As per recommended storage condition of the product.