Schedule For Medical Devices

Schedule Of Medical Devices:

Schedule Of Medical Devices Presented By –ALOK KR VISHWAKARMA RAVI KESHRI BIPIN KATIYAR M.Pharm(Pharmaceutics) PSIT KANPUR

GENERAL REQUIREMENTS:

GENERAL REQUIREMENTS Location and surroundings- The factory building shall be located in a sanitary place and hygienic conditions shall be maintained in the premises.Premises shall not be used for residence or inter connected with residence .It shall be well ventilated and clean . Buildings- The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insects ,rodents,flies etc. The walls of the rooms in which manufacturing operations are carried out, shall be up to a height of 6 feet from the floor , be smooth , water-proof and capable of being kept clean. Water Supply- The water used in manufacture shall be potable quality.

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Disposal of waste- Suitable arrangements shall be made for disposal of waste water . Health ,clothing and sanitation of workers- All workers shall be free from contagious or infectious diseases. They shall be provided with clean uniforms, masks, headgears and gloves wherever required. Washing facilities shall also be provided. Medical services-A dequate facilities for first-aid shall be provided. The premises shall be kept under controlled conditions of temprature and humidity so as to prevent any deterioration in the properties of materials and products due to storage and process conditions.

2-Requirements OF Manufacture of Medical Devices-:

2-Requirements OF Manufacture of Medical Devices- 1-Moulding (start from granules) 2-Assembling (cutting, washing, drying ,sealing, packing, labelling etc) 3-Raw materials 4-Storage Area 5-Washing , drying, sealing area The process of manufacture of medical devices shall be conducted at the licensed premises ,wherever required,and shall be divided into the following separate operations/sections- 6-Sterilization 7-Testing facilities

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The following equipments and space are recommended for the basic manufacture of different categories of medical devices A. Sterile Disposable perfusion and blood Collection Sets (1) Moulding A. Injection Moulding Machine B. Extruder Machine C. PVC Resin Compounding Machine (2) Assembling A. Hand Pressure Machine for filter fixing a Drip chamber B. Bag sealing machine C.Leak testing bench D. PVC tube cutting machine E. Compressor machine

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An area of 30 squre meters for moulding and 15 squre meters for assembling are recommended for basic installation . NOTE- An additional area of 20 squre meters is recommended for any extra category.

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B.Sterile Disposable Hypodermic SYRINGES. 1.Moulding A.Granulator B.Injection Moulding Machine C. Air Compressor D. Weighing devices 2.Assembling A.Blister Pack Machine B. Vacuum Dust Cleaner C. Rubber tip Washing Machine D. Foil Stamping or screen printing equipment The assembling area shall be air –conditioned provided with HEPA filters.

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C.Sterile Disposable Hypodermic Needles. 1.Moulding A.Needle grinding and levelling machine B. Electropolishing Machine C. Cutting Machine D. Injection Moulding Machine E. Needle Pointing Deburrine Machine F. Air-Compressor 2.Assembling: A. Needle cleaning machine with magnetic separator B. Blister Packing Machine C. Needle Inspection Unit

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3.Raw Materials - The licencee shall keep an inventory of all raw materials to be used at any stage of manufacture of devices and shall maintain records as per Schedule U.They shall be conspicuously labelled indicating the name of the material,control reference number,name of the manufacture and be specifically labelled “Under Test” or “Approved” or “Rejected”. The under test approved or rejected materials shall appropriately be segregated. These shall be tested for compliance with required standards of quality. A minimum area of 10 square meters shall be provided for storage of them.

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4.Storage Area- The licensee shall provide separate storage facilities for quarantine and sterilized products. 5.Washing, drying, and sealing area- The licensee shall provide wherever required adequate equipments like water distillation still, deionizer, washing machine, drying over with trays for washing , drying and sealing of medical device. 6.Sterilization 7.Testing facilities 8.Records- The licensee shall maintain records of different manufacturing activities with regard to each stage of manufacture in process controls, assembling ,packing, batch records for the quantity of devuces manufactured from each lot of blended granules duration of work.

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THANKS