Manufacturing Process Assignment: Analysing The Use Of Risk Based Approach For All Better Now Pty Ltd
Question
Task: 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.
Answer
Introduction
The report on manufacturing process assignment will deliver on the comparison of the manufacturing processes that are associated with the two types of product, which includes the terminally sterilised and the aseptic products. The study used to develop this manufacturing process assignment will contrast the appropriateness of each approach in terms of the Sterility Assurance, Bioburden Control, Media Trial studies, Cleanroom requirements and Environmental monitoring of the products.
Sterility Assurance
The aspect of the sterility assurance described in the manufacturing process assignment has been understood to be one of the major processes in the drug manufacturing operations (Sandle, 2013). It has been supported by the fact that the aseptic filling of the drugs is one of the serious processes in the case of the terminally sterilised and the aseptic production of the drug. It has been understood that the NDA approaches and the top-down validation approaches have surfaced as the most popular processes within the pharmaceutical industry, when it comes to the instantiation of the sterility assurance on the products (Bruch, 2018). The NDA approaches has been advised for the terminally sterilised products of All Better Now Pty Ltd as it has the technical capabilities of installing the system that can deliver on the prominence of undertaking the Moist Heat Sterilisation. The implications of the Risk Based Approach (top down validation approach) has been selected to prepare this manufacturing process assignment for the aseptic products of All Better Now Pty Ltd as its integration would complement the sterilisation process that has been stipulated in the company’s process maps.
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NDA (New Drug Application) approach |
Risk Based Approach (Top Down Validation Approach) |
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· It has been elected for its prowess in reducing the maintaining the Bioburden based cycle as it would further improve the rate of upstream bioburden minimisation when it comes to the production of the terminally sterilised product. · The approach is vested with the technologies of the Container closure integrity testing, which is an clinical incorporation within the processes of terminally sterilised product as in the process of terminal sterilisation, the sterilisation is done in the final product. |
· The risk based assessment has been opted as it will use its thorough sterilisation techniques and minimize the chances of microbial contamination that is associated with the final product as aseptic processing is known to possess higher risk of microbial contamination as compared to the terminally sterilised process |
Table 1: Comparison of the differences in Sterility Assurance approach between the 2 types of products
Bioburden Control
The manufacturing process assignment examines the role of bioburden control that has been understood to provide the products with the facets of minimal microbial contamination. It has been realised as one of the important procedures within the settings of the pharmaceutical industry. The process defines the number of the microbes that have been living on the surface as is not subjected to the cause of the sterilisation. The components or the end products that result out from the process need to meet certain control of microbial levels in the fields of the processing and handling. The facets of the Bioburden control helps in proving the fact that such requirements have been met. The process of the Plate count method has been suggested in the case of the terminally sterilised products of All Better Now Pty Ltd. The Membrane Filtration Method has been implemented in controlling the bioburden that is resultant from the upstream processes of the aseptic processes.
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Membrane Filtration Method approach |
Plate Count Method approach |
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· It has been selected as the company has installed a three tier filtration system within the facility in order to reduce the chances of microbial contamination and the induction of this approach with a membrane of pore size 0.45 micro millimetre will serve to the interests of the three tier filtration system · It has higher rate of accuracy in terms of calculating microbial count (Sandle, 2013) |
· The terminally sterilised products are known to possess a low bioburden and it has been understood that Plate Count Method provides effective result for the products that are considered to have low bioburden. Thus the Plate Count Method has been suggested for Bioburden Control while evaluating the terminally sterilised products · It has lower rate of accuracy in terms of analysing microbial count but the process does not result in significant amount of bioburden. Thus it would not pose as a predicament. |
Table 2: Comparison of the differences in Bioburden Control approach between the 2 types of products
Media Trials
The results that are procured through the undertaking of a trial run provides the product with a scope of making it to the market and is considered as the aspect that decides the fate of the pharmaceutics (Pocock, 2013). It has been understood that the stages of the clinical trials are designed with precision as the information that is relayed by it simulates for the efficiency of the drug on a practical scale (Piantadosi, 2017). This phase is considered to test for the clinical as well as the commercial viability of the product. Thus, from the analysis developed in this segment of manufacturing process assignment, the prospect of clinical trials needs to be met by the All Better Now Pty Ltd, in order to come good on the production of the terminally sterilised and the aseptic products. The approach of the treatment trials has been selected for the manufacturing of the terminally sterilised products of All Better Now Pty Ltd. The adaptive clinical trials have been selected for the production of the aseptic products of All Better Now Pty Ltd.
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Treatment trials |
Adaptive clinical trials |
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· It has been selected as the approach approves the efforts of conducting the experimental treatments where the diseased patient are treated as the test subject as the terminally sterilised product has minimized chances of bacterial contamination, thus the use of such clinical trails is deemed suitable · It can be used in order to test for the combination of two or more new drugs |
· The aseptic product is treated for microbial contamination in every subsequent step of production. Hence the use of such approach is more effective as Adaptive clinical trials provides room for medication of the trial runs while the process continues. · It is not suitable for testing out a combination of drugs and is assessed through the models of the Bayesian experimental design. |
Table 3: Comparison of the differences in Media Trials approach between the 2 types of products
Cleanroom requirements
It has been understood that the presence of a well maintained facility is extremely important to the production of pharmaceutics. The Cleanroom requirements has to be in accordance to the stipulations that has been mentioned in ” International Standard ISO 14644, Cleanrooms and controlled environments-Part 1: Classification of air cleanliness, and Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1”., in order to achieve the ISO class 5. The use of effective cleaning techniques is one of the major preventive measures that come down hard on the plausibility of a possible microbial contamination. The production that involves the manufacturing of the aseptic product has to be instantiated with the HEPA filters. It is one of the major recommendations provided in this manufacturing process assignment that could be suggested to All Better Now Pty Ltd. The air change rate has been considered as a recommendation to the All Better Now Pty Ltd for the processes that includes the manufacturing of the terminally sterilised product.
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Air change rate |
HEPA filters |
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· The air quality of the terminally sterilised manufacturing department stays high normally but the air within the room needs to be changed on a regular basis. This can be actuated through the implementation of the air change per hour (ACH) approach and thus has been proposed as a cleaning requirement within All Better Now Pty Ltd. · It can reflect on 20 and 40 air changes per hour. |
· HEPA filters are known to remove the airbone impurities of specific sizes with clinical efficiency and it is also understood the aseptic products are associated with higher probability of microbial contamination. Thus the implementation of HEPA filter will reduce the probability and will suit to the requirements of keeping a clean environment · The systems cannot change the air within the production facility. |
Table 4: Comparison of the differences in Cleanroom requirements approach between the 2 types of products
What is the role of environmental monitoring in the present context of manufacturing process assignment?
The environmental monitoring has been considered as one of the important facets of the manufacturing process as the premises need to be checked for its quality in terms of hygiene and sterile factors (Lorcheim and Hughes, 2012). It has been understood from the findings obtained in this manufacturing process assignment that the use of the stringent polices helps in improving the environment of the production facility. The routine monitoring approach has been used in the production of the terminally sterilised entities of the All Better Now Pty Ltd whereas the Volumetric air sampling approach for microorganisms has been used for the development of the aseptic products of the All Better Now Pty Ltd.
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Routine monitoring approach |
Volumetric air sampling approach for microorganisms |
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· It has been selected as the process checks for the prevalence of Grade A requirements within the setup and poses as a necessary parameter when it comes to the production of the terminally sterilised entities. |
· It has been elected, as the aseptic pharmaceutics is known to possess a elevated tendency of microbial contamination and the provisions of Volumetric air sampling approach for microorganisms could mitigate it by evaluating production strains, EM isolates |
Table 5: Comparison of the differences in Environmental monitoring approach between the 2 types of products
Conclusion
The report on manufacturing process assignment has been exemplary in understanding the requirements that are associated with the manufacturing of the terminally sterilised and aseptic products. It has been realised through the study developed in this manufacturing process assignment that the use of the risk based approach is of paramount importance to the growth of the sterility assurances compliances
Reference List
Sandle, T., 2013. Manufacturing process assignment Sterility, sterilisation and sterility assurance for pharmaceuticals: technology, validation and current regulations. Elsevier.
Bruch, C.W., 2018. Quality assurance for medical devices. In Pharmaceutical Dosage Forms (pp. 487-525). Routledge.
Sandle, T., 2013. A new standard for bioburden testing: USP chapter in development. GMP review. 12. 10-12.
Pocock, S.J., 2013. Clinical trials: a practical approach. John Wiley & Sons.
Piantadosi, S., 2017. Clinical trials: a methodologic perspective. John Wiley & Sons.
Lorcheim, P. and Hughes, M., 2012. Environmental Monitoring and Decontamination of Pharmaceutical Production Facilities. Manufacturing process assignment Pharmaceutical Engineering.
