REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF MEDICAL DEVICES

(A). GENERAL REQUIREMENTS:
(i) Location and surroundings: The factory building(s) shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Premises shall be not used for residence or be interconnected with residence. It shall be well ventilated and clean.
(ii) Buildings: The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insets, rodents, flies etc. The walls of the rooms in which manufacturing operations are carried out, shall be up to a height of six feet from the floor, be smooth, water proof and capable of being kept clean. The floor shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust.
(iii) Water supply: The water used in manufacture shall be of potable quality.
(iv) Disposal of waste: Suitable arrangements shall be made for disposal of wastewater.
(v) 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.
(vi ) Medical Services: Adequate facilities for first-aid shall be provided.
(vii) Workbenches shall be provided for carrying out operations such as moulding, assembling, labeling, packing etc. such benches shall be fitted with smooth impervious tops capable of being washed.
(viii) Adequate facilities shall be provided wherever required for cleaning, washing, drying of different containers of devices.
(ix)The premises shall be kept under controlled conditions of temperature and humidity so as to prevent any deterioration in the properties of materials and products due to storage and process conditions.
(B). Requirements for Manufacture of Medical Devices:
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
(1). STERILE DISPOSABLE PERFUSION AND BLOOD COLLECTION SETS.
(a) Moulding: wherever manufacture of medical devices is to start from granules.
 Injection Moulding Machine.
 Extruder Machine.
 PVC Resin compounding Machine.
(b) Assembling: include cutting, washing and drying, sealing, packing, labeling, etc.
 Hand Pressing Machine for filter fixing a Drip Chamber.
 Bag Sealing Machine.
 Compressor Machine.
 Leak Testing Bench
 PVC Tube Cutting Machine.
 Tube Winding Machine (wherever necessary).
 Welding Machine (wherever necessary)
• An area of 30 square meters for Moulding and 15 square meters for Assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The moulding section shall, if necessary, have proper exhaust system.
Note: – An additional area of 20 square meters is recommended for any extra category.
(2). STERILE DISPOSABLE HYPODERMIC SYRINGES:
(a) Moulding: –
 Granulator
 Injection Moulding Machine.
 Weighing devices.
(b) Assembling:
 Blister Pack Machine.
 Vacuum Dust Cleaner
 Rubber-tip Washing Machine
 Foil stamping or screen printing equipment.
• An area of 30 square meters for moulding and 15 square metres for assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA Filters. The moulding section, shall, if necessary, have proper exhaust system.
Note: – An additional area of 20 square meters is recommended for any extra category.
(3). STERILE DISPOSABLE HYPRODERMIC NEEDLES:
(a) Moulding:
 Needle grinding and leveling machine.
 Electro Polishing Machine.
 Cutting Machine
 Injection Moulding Machine.
 Needle Pointing Deburrine Machine
 Air-compressor.
(b) Assembling:
 Needle cleaning Machine with Magnetic Separator.
 Blister Packing Machine.
 Needle Inspection Unit.
• An area of 30 square meters for Moulding and 15 square meters for Assembling are recommended for basic installation. The assembling area shall be air-conditioned provided with HEPA filters. The molding section shall, if necessary, have proper exhaust system.
Note: – An additional area of 20 square meters is recommended for any extra category.
(C). Raw Materials: The licensee 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. All such raw materials shall be identified and assigned control reference umber. They shall be conspicuously labeled indicating the name of the material, control reference number, name of the manufacturer and be specially labeled 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 raw materials.
D. Storage Area: The licensee shall provide separate storage facilities for quarantine and sterilized products.
• An area not less than 10 square meter shall be provided for each of them.
E. Washing, drying and sealing area: The licensee shall provide wherever required adequate equipments like water distillation still, deionizer, washing machine. Drying Oven with trays for washing, drying and sealing of medical device.
• An area not less than 10 square metre shall be provided.
F. Sterilization: The licensee shall provide requisite equipments with required controls and recording device for sterilization of medical devices by Ethylene Oxide Gas in his own premises or may make arrangements with some Institution approved by the Licensing authority for sterilization. The products sterilized in this manner shall be monitored to assure acceptable levels of residual gas and its degradation products.
• An area of 10 square meters is recommended for basic installation of such facility. Provided that the above equipment may not be required in case the licensee opts for sterilization of medical devices by Ionizing Radiation.
G. Testing Facilities: The licensee shall provide testing laboratory for carrying out Chemical and Physio-Chemical testing of medical devices and of raw materials used in its own premises: Provided that the Licensing Authority shall permit the licensee in the initial stage to carry out testing of Sterility, Pyrogens, Toxicity on their products from the approved testing institutions but after one renewal period of licensee shall provide testing facilities of all such tests in their own premises.
H. Records: The licensee shall maintain records of different manufacturing activities with regard to each stage of manufacture in-process control, assembling, packing, batch records for the quantity of devices manufactured from each lot of blended granules, duration of work, hourly quantum of production in respect of each item as well as record of each sterilizing cycle of the gaseous method employed.
Note: – The above requirements of machinery, equipments, space, qualifications are made subject to the modification at the discretion of the Licensing Authority, if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances of a particular case.
Please find all related article links of SCHEDULE M below-
SCHEDULE M-II-REQUIREMENT OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS

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