ü Factors associated with the longest permitted run on the processing line that can pose contamination risk.
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Get Help Now!ü Representative number, type, and complexity of normal interventions that occur with each run, as well as non-routine interventions and events.
ü Aseptic assembly of equipment.
ü Number of personnel and their activities.
ü Representative number of aseptic additions (example charging containers and closures as well as sterile ingredients) or transfers.
ü Shift changes, breaks and gown changes.
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Module CHE70006/HES6413 Good Aseptic Practices and Sterile Products Final Semester Assignment This assignment is designed to evaluate your understanding and application of Good Aseptic Practices and its implications for sterile product manufacturing. The assignment will be assessed on the correct application of Good Aseptic Practices and Sterile Products principles and on the ability of the document to convey the necessary information. The assignment is worth 20% of the subject marks and must be 1500 words +/- 10%. Assignment length outside these limits will incur loss of marks. The assignment must be uploaded to Turnitin on Blackboard on or prior to the submission date. Any submission after the due date will be managed according to the subject outline rules for late submissions. Assessment Criteria: The assignment will be assessed on a number of technical areas including quality of authorship,. Marks will be allocated as follows: The report should demonstrate a clear understanding of the requirements for 80% aseptic manufacturing, sterility assurance, fundamental differences between aseptic processing and terminal sterilized products, bioburden control, cleanroom/area requirements and the use of risk based strategies. Quality of Authorship – Report/ presentation, structure, referencing, research 20% ability, document structure, grammar, compliance with GMP requirements for document control, correct referencing Doc No. AF6413_05_1_01 Ver 1.0 © SeerPharma Pty Ltd Page 1 of 4Module CHE70006/HES6413 Good Aseptic Practices and Sterile Products Background All Better Now is a pharmaceutical company considering manufacturing and supplying in Australia a range of Sterile Pharmaceutical products. Some of their products are manufactured aseptically (for example: succinylcholine chloride injection) and others are terminally sterilised (for example sterile ophthalmic solution). The company has…
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