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equipment for large scale paretral and quality control

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equipment for large scale manufacture

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equipment for large scale paretral and quality control

  1. 1. EQUIPMENTS FOR LARGE SCALE MANUFACTURE FOR PARENTRAL PRODUCTS PRESENTED BY : KUMAR SATYAM • 2271010017 GUIDED BY • Dr. S. SANGEETHA 1
  2. 2. EQUIPMENTS The following equipments as per schedule- M has been recommended a. Manufacturing area:  Storage equipment for ampoules , vials & closures  Washing and drying equipments  Dustproof storage cabinet  Water still  Mixing and preparation tanks or other containers  Mixing equipments  Filtering equipments hot air sterilizer 2
  3. 3. b) Aseptic filling and sealing rooms:  Benches for filling and sealing  Bacteriological filters  Filling and sealing unit under laminar flow work station c) General Room :  Inspection table  Leak testing table  Labeling and packing benches  Storage of equipment including cold storage and refrigerators (if necessary) 3
  4. 4. STERILE GARMENT CABINET Stainless steel  Sterility is maintained by use of UV disinfectant  May be designed horizontal air flow system and clean air through HEPA filter  4
  5. 5. HEPA FILTER     HEPA filters can remove at least 99.97% of airborne particles 0.3 µm in diameter. HEPA filters are composed of a mat of randomly arranged fibers. Key factors affecting function are fiber density and diameter, and filter thickness. The air space between HEPA filter is much greater than 0.3µm. The common assumption that a HEPA filter acts like a sieve where particles smaller than the largest opening can pass through is incorrect. 5
  6. 6. TYPES OF CONTAINER FOR PARENTERAL AMPOULES • Intended for single use • Product must be filtered before use VIALS • Glass or plastic containers are closed with a rubber stopper and sealed with an aluminum crimp PREFILLED SYRINGE • Intended for quickest administration 6
  7. 7. AMPOULE WASHING MACHINE Thoroughly cleaned with detergents. Washed with tap water & distilled water finally rinsed with water for injection 7
  8. 8. VIAL WASHING MACHINE It has several channels for washing of the vial. The vials travel through these channels and simultaneously purified water , air ,water for injection, are introduced through various nozzles and arranged in the washing machine. •After washing completes the vial run through depyogenation zones. •Here the ampoules /vials are made to free from pyrogens (sterilization is done here) 8
  9. 9. FILLING MACHINE AMPOULE FILLING MACHINE • Filling range is between 1 ml - 20 ml. • At the mean time Sealing is done either by laser sealing system or conventional gas flame VIALS FILLING • The comprises of an intake section which loads the vials • Transferred through an intermittent transport section. • Liquid filling section which fills the vials with predetermined quantity. • Finally the filled and rubber Stopperd vials are released and discharged. 9
  10. 10. QUALITY CONTROL  The three general area of quality control are incoming stock, manufacturing and the finished product.  Types of Quality Control: LEAKERS TEST CLARITY TEST PYROGEN TEST STERILITY TEST • • • • 10
  11. 11. LEAKERS TEST This test is to detect incompletely sealed ampoules. The sealed ampoules are subjected to small cracks which occurs to rapid temperature changes or due to mechanical shock Filled and sealed ampoules Dipped in 1% methylene blue solution under negative pressure in vacuum chamber Vacuum released coloured solution enter into the ampoule Defective sealing Vials and bottles are not suitable in this test because the sealing material is not rigid.
  12. 12. CLARITY TEST         A clear having a high polish conveys product is of exceptional quality and purity. Practically impossible to prepare sterile product perfectly free from visible particulate matter(size 30-40 µm). Quality control departments responsibility – to detect and discard unclean products. USP states that good pharmaceutical practice requires that all containers be visually inspected and that any with visible particles may be discarded. For large volume infusions,the USP has established a limit of 50 particles of 10 µm and larger and five particles of 25 µm and larger per ml. Visual inspection of products containers usually done by individual human inspection of each externally clean container under a good light and viewed against a black and white background. Contents set in motion with a swirling action. Instrumental method of evaluation of particles utilizes principles of light scattering, light absorbtion and electrical resistance for particle count and size distribution.
  13. 13. PYROGEN TEST Pyrogen test Rabbit test LAL test 13
  14. 14. RABBIT TEST Rabbits are used as the test animal because they show a physiological response to pyrogens similar to that of human beings.  3 healthy adult rabbits of either male or female, each weighing not less than 1.5 kg are selected.  14
  15. 15. METHOD Normal Temperature is recorded prior to the test Dilute the test substance in pyrogen free saline solution Test solution is injected through an ear vein Volume of injection is maintained between 0.5 10ml/kg Warm the solution to 38.5oC Body temperature is recorded by a clinical rectal thermometer Record temperature at an interval of 30min for 3hr The difference between initial and final temperature is recorded 15
  16. 16. LAL TEST LIMULUS AMEBOCYTE LYSATE TEST • • To detect endotoxins of gram negative bacterial origin. Reagent: Amebocytes of Limulus polyphemus. Technique: Gel Clot technique:  In the presence of pyrogenic endotoxins from gram –ve bacteria , a firm gel is formed within 60 min when incubated at 37º C. 16
  17. 17. METHOD  Equal Volume of LAL reagent and test solution (usually 0.1 ml of each) are mixed in a depyrogenated test-tube  Incubation at 37°C, 1 hour  Remove the tube  Invert at (180°) observe the result  Pass-fail test(GEL FORMATION) 17
  18. 18. STERILITY TEST It is a procedure carried out to detect confirm absence of any viable form of microbes in product. Principle: sterlity testing only shows that organisms capable of growing in selected conditions are absent from the fraction of batch that has been tested. If the microorganism are present in the product can be indicated by a turbidity in the clear medium. Objective of Sterility Testing:  For validation of sterilization process  To prevent issue of contaminated product in market  To check presence of microorganism in preparation which are sterile 18
  19. 19. REFERENCE: INDUSTRIAL PHARMACY • Leon Lachman • Herbert A. Lieberman WWW.PHARMAMACHINE.COM • www.authorstream.com • PHARMALES.CO.IN 19
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