Pharmaceutical manufacturing plant

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Pharmaceutical manufacturing plant

  1. 1. Pharmaceutical Manufacturing Plant Rakesh Kumar Sharma R.K Sharma 1
  2. 2. Locations and SurroundingsThe factory building (s) for manufacture ofdrugs shall be so situated and shall have suchmeasures as to avoid risk of contaminationfrom external environment including opensewage, drain, public lavatory or any factorywhich produces disagreeable fumes, excessiveshoot, dust, smoke, chemical or biologicalemissions R.K Sharma 2
  3. 3. Location► Premises must be located to minimize risks of cross- contamination; e.g. not located next to a factory with high airborne levels of fungi and yeast► Photograph shows a liquid oral manufacturing unit situated close to a factory producing Malt preparations► This has caused high degree of microbial contamination R.K Sharma 3
  4. 4. Formulation factories may not be located wherever the land or plot is available►Geography – Free from geographical disturbances such as earthquakes►Climate – Free from disturbances such as floods R.K Sharma 4
  5. 5.  Adequately provided with working space to allow orderly and logical placement of equipments, materials, and movement of personnel so as to: ►avoid the risk of mix-up between different categories of drugs or with RM, intermediates and in-process materials. ►avoid the possibilities of contamination and cross contamination by providing suitable mechanism R.K Sharma 5
  6. 6. ►Designed / constructed / maintained to prevent entry of insects, pests, birds, vermin & rodents.►Interior surfaces (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning, painting and disinfection R.K Sharma 6
  7. 7. ► Airconditioned, wherever prescribed for the operations and dosage forms under production.► The production and dispensing areas shall be  well lighted,  effectively ventilated with air control facilities  may have proper Air Handling Units (wherever applicable) to maintain conditions including ►temperature and wherever necessary humidity as defined for relevant product.► These conditions shall be appropriate to the category of drugs and nature of operations. R.K Sharma 7
  8. 8. ► The walls and floors of the areas where manufacture of drugs is carried out shall be free from cracks and open joints to avoid accumulation of dust.  These shall be ►smooth ►washable ►coved and ►shall permit easy and effective cleaning and disinfection. R.K Sharma 8
  9. 9. ► These shall also be suitable to the comforts of the personnel working with  protective clothing,  products handled,  operations undertaken within them in relation to the external environment► Theseareas shall be regularly monitored for compliance with the required specifications. R.K Sharma 9
  10. 10. Other Areas► Personnel rest areas/cafeterias/changing rooms  away from operating areas  prevention of cross-contamination  prevention of operators going outside in work clothes  provision of access control  prevention of visitors access to operating areas► Maintenance service areas  separated from production areas whenever possible R.K Sharma 10
  11. 11. Finish of Floors, Walls and Ceilings► Difficult but not impossible to get correct surfaces► Smooth, impervious, hard-wearing, easy to clean► Resistant to operations and materials in use► Windows not opening to the outside► Avoid sliding doors R.K Sharma 11
  12. 12. ►A much better Finish of Floors, Walls and Ceilings could look like this. The surfaces are epoxy painted and interior surfaces are made smooth R.K Sharma 12
  13. 13. Design Principles for logical work flow should be considered with following aspects► Process flow► Material flow R.K Sharma 13
  14. 14. Design Principles for logical workflow should be considered with following aspects Material flow People flow QC Offices Canteen Gowning Incoming goods Shipping Corridor Corridor Corridor Raw Materials Finished Packaging & Filling Products Packaging Weighing Processing Storage Storage Washing Machine Shop Corridor Utilities and Services Waste Treatment R.K Sharma 14
  15. 15. Manufacturing and Packaging Areas► Pipe-work and other fittings placed to avoid recesses► Drain design:  equipped to prevent backflow  open channels avoided► Effective air handling to suit product  Temperature  Humidity  Air filtration  Environment monitoring R.K Sharma 15
  16. 16. Manufacturing and Packaging Areas► Specifically designed and laid out to avoid mix-ups and cross-contamination  Changing facilities to provide segregated access► Prevention of cross-contamination► Suitable lighting levels R.K Sharma 16
  17. 17. In-Process and QC laboratories► Located separate from but near manufacturing  prevention of cross-contamination  separate biological & microbiological areas► Designed for the operations being carried out  suitable storage space R.K Sharma 17
  18. 18. Design aspects - Tablets► Lay out for Tablets could be ► Room for Weight checking, Sifting, Milling, Mixing, Granulation ► Room for Paste preparation ► Room for Drying – FBD and or Tray driers ► Room for Equipment Washing ► Room for maintenance of clean equipment ► Compression cubicles ► IPQC area ► Coating Area  Coating solution preparation  Sugar & Film coating operations, drying (if necessary) - a tray drier ► Inspectionarea ► Quarantine Area ► Packing Area Strip Blister or Bulk R.K Sharma 18
  19. 19. Materials Flow - Tablets► Receipt of Dispensed RM ► Sifting  Mixing  Granulation  Wet Milling  Drying  Milling  Lubrication► Blend Analysis  Compression ► Quarantine  QA release  Inspection  Primary Packing or► Coating  Inspection  Primary Packing ► Secondary Packing R.K Sharma 19
  20. 20. Design aspects - Liquid Oral Preparations► Sugar Syrup Preparation area► Area for preparation of solids for suspension► Compounding and filtration / Homogenization area► Equipment washing area and area for maintaining clean equipment► Bottle washing area► Filling area► Labeling and packing area R.K Sharma 20
  21. 21. Materials Flow - Liquid Oral preparations (Syrups and Suspensions)► Receipt of Dispensed RM ► Weight Checking ► Milling (for suspensions)  Sifting (for suspensions)► Syrup Preparation ► Compounding  Filtration or Homogenizing  QC Approval ► Bottle Washing  Filling & Sealing ► Checking Packing R.K Sharma 21

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