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Autoclave PPT

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Autoclave PPT

  1. 1. www.julphar.net Gulf Pharmaceutical Industrieswww.julphar.net Gulf Pharmaceutical Industries Autoclave (Steam sterilizer) October 2015 Prepared By: Vishal Katiyar
  2. 2. www.julphar.net Gulf Pharmaceutical Industries Introduction and history  The name comes from Greek auto-, ultimately meaning self, and Latin clavis meaning key—a self- locking device.  1450 B.C.E. Moses 460-377 B.C.E. Hippocrates Pasteur Denis Papin  The autoclave was finally created by Charles Chamberland- A French microbiologist.
  3. 3. www.julphar.net Gulf Pharmaceutical Industrieswww.julphar.net Gulf Pharmaceutical Industries Transformation in design BEFORE AFTER
  4. 4. www.julphar.net Gulf Pharmaceutical Industries Equipment design & components Utility required 1. Pure steam 2. Boiler steam 3. Vaccum pump supply 4. Compressed air 5. Purified water
  5. 5. www.julphar.net Gulf Pharmaceutical Industries Basic operation
  6. 6. www.julphar.net Gulf Pharmaceutical Industries Types of sterilizers Gravity Displacement sterilizers Dynamic air removal (with vaccum pump) sterilizers Only for terminal sterilization Terminal and porous load sterilization
  7. 7. www.julphar.net Gulf Pharmaceutical Industries Sterilization in Julphar Types of Load Non-porous loads Porous loads  Also called Hard goods load. Liquid load for terminal sterilization Media cycles in microbiology lab.  No pre- post vaccum required  Sterilized by gravity displacement method or sterilizers. Also called wrapped goods load.  Pre and post vaccum required Glassware and unwrapped load in microbiology lab.  Pre and post vaccum required  Sterilization of garments, silicon tubing, filters, machine parts, rubber stoppers and seals.
  8. 8. www.julphar.net Gulf Pharmaceutical Industries Sterilization in Julphar Production Loads Machine parts load Garments load
  9. 9. www.julphar.net Gulf Pharmaceutical Industries What is Sterilization Sterilization can be defined as any process that effectively kills or eliminates microorganisms, their spores and vegetative cells (such as fungi, bacteria, viruses) from a surface, equipment, or biological culture medium. The level of microbiological inactivation can be described by an exponential function called SAL (Sterility assurance level). For example: A SAL of 10-6 of means that the probability of single microorganism being present on sterilized item/ article is one in one million after it undergone through sterilization process. Steam sterilization can be defined by log reduction in population of microorganisms.
  10. 10. www.julphar.net Gulf Pharmaceutical Industries How steam sterilization works Steam is an effective sterilant for two reasons. First, steam is an extremely effective “carrier” of thermal energy. It is many times more effective in conveying this type of energy to the item than is hot (dry) air. Due of its high heat of enthalpy: 438 KJ/ mole Second, steam is an effective sterilant because any resistant, protective outer layer of the microorganisms can be softened by the steam , allowing coagulation of the sensitive inner proteins of the microorganism. Sterilization parameters: Temperature: 121.1°C (considered as base temperature for sterilization) Pressure: 15 lbs (1.12 Bar) Time: 15 to 30 minutes (time shall be vary according to approach of sterilization)
  11. 11. www.julphar.net Gulf Pharmaceutical Industries Sterilization Approach Two types of sterilization approach Overkill Approach Bioburden Approach Overkill sterilization primarily is applied to the moist-heat processing of materials, supplies, and other heat-stable goods. "This is usually achieved by providing a minimum 12-log reduction of microorganisms considering worst case of D- value at 121.1 °C. For items that are heat sensitive and can not withstand an overkill approach. It is necessary to collect the bioburden data and possibly D-value data. This will reduce the sterilization cycle time. For example: 134 CFU(bioburden) To reduce the bioburden from 134 to 01 = log (134) = 2.14 minutes.
  12. 12. www.julphar.net Gulf Pharmaceutical Industries D and Z value D-value refers to decimal reduction time and is the time required at a given temperature to kill 90% of the exposed microorganisms or to reduce the population by 1 log reduction.
  13. 13. www.julphar.net Gulf Pharmaceutical Industries D and Z value Z- value is the temperature required for one log10 reduction in the D-value.
  14. 14. www.julphar.net Gulf Pharmaceutical Industries Performance qualification Validation equipment used in performance Qualification or re- qualification. Kaye Validator SIM (sensor input module Thermocouple Kaye Validator set-up Feed-through
  15. 15. www.julphar.net Gulf Pharmaceutical Industries Performance qualification • 1. Chamber vaccum leak test Objective: Objective of this test is to check the integrity of chamber and ensure that the rate of vacuum drop is within the acceptable limits. • Acceptance criteria: 1.3mbar/ minute • Use: To ensure microorganisms and air entrance into autoclave chamber. Test to be carried out in performance Qualification or re- qualification.
  16. 16. www.julphar.net Gulf Pharmaceutical Industries Performance qualification 2. Bowie-Dick test Objective: Pre-vaccum pulses are sufficient to remove the entrapped air or non-condensable gases so as to facilitate rapid and even steam penetration into all parts of the load. • Acceptance criteria: Test- kit colour should change from yellow to black . Use: To ensure complete removal of air from autoclave chamber through pre-vaccum pulses.
  17. 17. www.julphar.net Gulf Pharmaceutical Industries Performance qualification UNEXPOSED BOWIE-DICK KIT EXPOSED BOWIE-DICK KIT
  18. 18. www.julphar.net Gulf Pharmaceutical Industries Performance qualification 3. Empty chamber heat distribution Objective: Objective of this test is to ensure that equipment is suitable for even dstribution of heat in the sterilizer chamber when operated with pre-defined parameters. • Acceptance criteria: Temperature: NLT 121°C Sterilization Time NLT 30 minute
  19. 19. www.julphar.net Gulf Pharmaceutical Industries Performance qualification HEAT DISTRIBUTION STUDY SENSOR LOCATION
  20. 20. www.julphar.net Gulf Pharmaceutical Industries Performance qualification 4. Heat penetration study Objective: Objective of this test is to ensure that equipment is suitable for sterilization of loaded articles in the sterilizer chamber. • Acceptance criteria: Temperature: 121°C – 124°C Sterilization Time NLT 30 minute Equilibration time:- NMT 30 Sec. Biological Indicator should not show any growth Use: To check and ensure sterilization of articles in load.
  21. 21. www.julphar.net Gulf Pharmaceutical Industries Performance qualification
  22. 22. www.julphar.net Gulf Pharmaceutical Industries Performance qualification
  23. 23. www.julphar.net Gulf Pharmaceutical Industries Performance qualification 5. Assurance of sterilization: Physical challenge: By temperature mapping. Chemical challenge: Autoclable tape.
  24. 24. www.julphar.net Gulf Pharmaceutical Industries Performance qualification 5. Assurance of sterilization: Biological challenge: By keeping the biological indicator (Geobacillus stearothermophilus, population = 106 ) inside the sterilizing articles. For Porous loads For Liquid loads
  25. 25. www.julphar.net Gulf Pharmaceutical Industrieswww.julphar.net Gulf Pharmaceutical Industries Thank you 

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