Control of sterilisation processes

• What does CCS stand for in the context of sterilization processes?

  CCS stands for Control of Sterilization processes.
• What is the purpose of quality control in the context of sterilization?

  Quality control ensures the testing of the final product.
• What is the aim of the designed process in sterilization?

  To allure all stages of the manufacturing process.
• How does the manufacturing process contribute to the final product?

  It contributes to the quality of the end product.
• What is the significance of validating the sterilization processes?

  It ensures that a process consistently produces results as intended.
• What is one method used for calibration in sterilization processes?

  Calibration of equipment.
• What is one aspect of steam quality testing?

  Leak tests.
• What types of indicators are tested in software validation?

  Physical, chemical, and biological indicators.
• What is the purpose of validation control in sterilization processes?

  • Ensures processes are effective
  • Confirms that sterilization methods are reliable
  • Validates that the end product meets quality standards
• What is one method of environmental control in sterilization?

  Air settle plates.
• What is another method of environmental control mentioned?

  Air samplers.
• What is a method used for testing surfaces in sterilization?

  Contact plates and swabbing.
• What is the role of process control in sterilization?

  It ensures quality assurance.
• What are methods used as indicators in sterilization processes?

  Physical indicators.
• What is recorded during the sterilization process?

  A digital record of temperature taken at the coolest part of the loaded sterilizer.
• What is one tool used for testing gaseous leaks in sterilization?

  Gaseous leak kits.
• What is a dosimeter used for in sterilization?

  It darkens in proportion to radiation.
• What is one method of testing pressure in sterilization?

  Nitrogen bubble paint pressure test.
• What do chemical indicators usually undergo during sterilization?

  Melting or color change.
• What does a chemical indicator not necessarily correspond to?

  It does not necessarily correspond to sterility.
• What is a characteristic of Browne's tubes during heating?

  They produce a color indicator that changes.
• What determines the color speed of Browne's tubes?

  The temperature.
• What is one type of biological indicator used in sterilization?

  Bacillus stearothermophilus.
• What is another biological indicator mentioned?

  Bacillus pumilus.
• What is included when validating a method in sterilization?

  A suspension of bacteria in a thermally processed medium.
• What happens to biological indicators after sterilization?

  They are incubated to check if sterilization failed.
• What is the purpose of a sterility test?

  To check for the presence of bacteria.
• What does the sterility test recognize?

  Only organisms that grow under test conditions.
• What can affect the sample size in sterility testing?

  Contamination may reduce the sample size.
• What is a factor in sampling for sterility testing?

  Probability of contamination.
• What does a probability net indicate in contamination?

  It indicates the likelihood of contamination.
• What is a parametric release in sterilization?

  A system that guides assurance that the product is of intended quality.
• What is the basis for parametric release?

  Data collected during manufacturing, not sterility results.
• What parameters must be accurately controlled in sterilization?

  Temperature, pressure, and nitrogen levels.
• What is required for products that are terminally sterilized?

  Validation methods such as penetration studies.
• What is cycle lethality in sterilization?

  It requires pre-validation bioburden testing of each batch.
• What is included in each sterilization cycle?

  Chemical or biological indicators.
• What is a pyrogen?

  A substance that causes fever by bacteria.
• What is one method for pyrogen testing?

  Rabbit pyrogen test (RPT).
• What is recorded during the rabbit pyrogen test?

  Temperature recorded over 3 hours.