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Key Principles
Key Principles
At the heart of aseptic processing is the commitment to sterility. This is achieved by implementing strong personnel, process, and environmental controls to minimize the potential for contamination.
Many products today are unable to be processed through a terminal sterilization process such as autoclaving or radiation. Those processes would cause damage to the product manufactured. For aseptic manufacturing, all incoming process materials including components, equipment, and the product constituents must be sterile from the beginning of the process.
Regulatory Compliance
Regulatory Compliance
There are several regulatory guidelines and best practice publications around Aseptic Processing. When making products that are unable to be terminally sterilized, strong aseptic technique is the only way to keep contamination out of the process. Compliance with current Good Manufacturing Practices (CGMP) and participating in regular inspections are mandatory to ensure the safety and efficacy of pharmaceutical products.
Challenges
Challenges
Despite rigorous protocols, aseptic processing presents challenges, including its complexity and the persistent risk of contamination. Validation of processes is crucial to demonstrate that they consistently produce sterile products. One of the most important components is successful APS (aseptic process simulation) to provide evidence that the environment, personnel, and components do not contribute contamination to the process.
It is critically important to create and deploy effective training programs to ensure that employees are provided the necessary knowledge and techniques to be successful.
Case Study:
Case Study:
Start-up CGT manufacturing facility
Start-up CGT manufacturing facility
Our client reached out to us and shared that they were having an issue training new hires in the basic skills required to contribute to the manufacturing process. In start-up mode, most of a site's key individuals are on the floor making products and don't have enough time to also train the next set of personnel. At the time of the request, it was taking at least three months to get a new hire past just the entry-level aseptic processing training.
After a few conversations, the proposed solution was to develop an entry-level aseptic processing program for the site. The design of the program aimed to condense those three months of training into one to two weeks.
As the new hires trickled in, regular onboarding and aseptic training programs were rolled out. Working together, we created a robust training program that began with a CGMP overview and concluded with a hands-on mock APS (aseptic process simulation) so that trainees could demonstrate the skills they had learned throughout the week.
Over 30 employees were provided to us on a rotating basis, and a combination of classroom and hands-on training was implemented to instill site aseptic processing behaviors. This program was delivered several times over a six-month period. The result was that the new personnel were able to support manufacturing efforts much sooner than ever before.
Aseptic processing is an essential aspect of pharmaceutical manufacturing, requiring meticulous attention to detail at every stage to ensure the delivery of safe and effective products to patients.
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