478. Industrial Pharmacy: A Comprehensive Approach Gas Sterilization Ethylene oxide (ETO) Is a colorless gas and usually harmless to most of the plastics. For this it is a common sterilizing agent for plastic materials. Ethylene oxide can penetrate cell of microorganism and react chemically with cell protein. The reaction is catalyzed by moisture and produces certain toxic substances-ethylene glycol and/or ethylenechloro- hydrin. Moreover, plastics can absorb residual ethylene oxide. For this reason it is better to avoid this method. Model Questions Questions carrying 1-2 marks 1. What are parenteral preparations? 2. Enlist the type of documents to be maintained for manufacture of sterile products? 3. What is meant by term Standard Operating Procedures? Name the information it contain? Why records of distribution to be maintained in pharmaceutical industry? How the cleaning of an area is expressed and an what basis itis classified? What is traffic system in manufacturing area? What is HEPA filter? What is hot DOP test? won ans Which class of packaging materials is to be sterilized and why? 10. Whatis siliconization? Why it is done? Questions carrying 3-5 marks 1. Whatdo you understand by production, scheduling and cantrol? 2, What is Master File and what does it inform? 3. How the personnel work in the sterile area is categorized and what ii importance of personnel in maintaining sterility? 4, Explain air distribution network in sterile product manufacturing area? the 5. How can airborne contamination be prevented? What are the forces that influence the design and selection of suitable system to control airborne particles? What is integrity test of alr-filtration system? Write down different classes of glass container and their use? How the glass containers are washed? How the plastic containers are sterilized? wane Ul O <