ü Factors associated with the longest permitted run on the processing line that can pose contamination risk. 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. gularly made curved keeping in mind the end goal to think the waves.
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
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
Any submission after the due date will be managed according to the subject outline rules for
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
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…