September 5, 2021: Pharmaceutical Interview Questions and Answers
#MonitoringOfMoistHeatSterilizationCycle #WrappingMaterialDuringSterilizationProcess #ChallangeTestForDepyrogination #SterilisationByRadiation #UnacceptableIrradiationForSterilization
1. How to monitor moist heat sterilization cycle?
Both temperature and pressure should be used to monitor the process. Control instrumentation should normally be independent of monitoring instrumentation and recording charts. Where automated control and monitoring systems are used for these applications they should be validated to ensure that critical process requirements are met. System and cycle faults should be registered by the system and observed by the operator. The reading of the independent temperature indicator should be routinely checked against the chart recorder during the sterilisation period. For sterilisers fitted with a drain at the bottom of the chamber, it may also be necessary to record the temperature at this position, throughout the sterilization period. There should be frequent leak tests on the chamber when a vacuum phase is part of the cycle.
2. Explain the quality of wrapping material used during sterilization process?
The items to be sterilised, other than products in sealed containers, should be wrapped in a material which allows removal of air and penetration of steam but which prevents recontamination after sterilisation.
3. What challenge should be carried out during validation when for dry heat sterilization when it is intended to remove pyrogen?
Challenge tests using endotoxins should be used as part of the validation.
4. In what scenario, sterilisation by radiation can be adopted?
Radiation sterilisation is used mainly for the sterilisation of heat sensitive materials and products. Many medicinal products and some packaging materials are radiation-sensitive, so this method is permissible only when the absence of deleterious effects on the product has been confirmed experimentally.
5. Which irradiation is not an acceptable method of sterilisation.?
Ultraviolet irradiation is not normally an acceptable method of sterilisation.
Reference: EudraLex – The Rules Governing Medicinal Products in the European Union Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1 – Manufacture of Sterile Medicinal Products – 01 March 2009