Pharmamedia Dr. Müller (PMM) is a leading manufacturer of culture media for environmental monitoring and is specialized in the production as well as the development of microbiological media for pharmaceutical applications. Triggered by customer requests, PMM continuously expands the product portfolio and always provides innovative products with a high level of quality and safety.
Safety is crucial when it comes to media for application in aseptic process simulation (APS). APS is the simulation of an aseptic filling process using a sterile nutrient and /or a surrogate instead of the product and is performed to verify the effectiveness of the controls put in place for the aseptic processing. APS is performed to initially validate an aseptic filling line and then at least twice a year for each filling line. Additional runs may be required in case of unexpected events such as process deviations, a failed APS, or non-conforming sterility results. According to regulations (EU GMP Annex I 2022-08 and PDA TR22), the target of APS is zero growth, and any contaminated units result in a failed APS. Consequently, the usage of a medium with a high level of quality and safety is extremely important to avoid positive results which would implicate an APS failure.
Pharmaceutical companies either manufacture media for APS in-house starting from Tryptic Soy Broth (TSB) granulate or they use ready-to-use media (TSB or animal-free alternatives).
Key features of PMM ready-to-use TSB for APS are:
- High media quality thanks to accurate selection of raw materials and meticulous incoming good controls
- High level of safety; TSB is autoclaved, sterile filtered and filled into a sterilized closed bag system
- Customizable. TSB filling volume can be adapted according to end user requirements
- Flexibility. Different types of connectors for connection to the filling line are available in each item
- Customer-focused: Each medium-filled bag is supplied with additional bags for quality control, incoming goods testing, and shelf-life validation, ensuring seamless testing and enhanced process efficiency.
Key advantages over the in-house production of media for APS are:
- Safety – autoclaved and sterile filtered medium filled in a sterilized bag
- Pre-filtered – if needed, a further sterile filtration is easily achievable
- Easy handling – the connection of the bag system to the filling line is the only handling step
- No risk of filter clogging – cold filtration of self-prepared media often results in clogging of the filter
- No need to clean and sterilize the containers for media preparation, which is often time-consuming and costly.
In addition to the already available articles (up to 45 L and up to 500 L TSB), PMM
- Is currently developing TSB in 10 L bags, double wrapped and irradiated
- Is happy to provide customized solutions on top
- Offers the possibility to fill customer-specific systems for APS
Ready to optimize your APS process? Contact us to learn how PMM’s innovative solutions can help you improve your aseptic processing, maintain compliance, ensure consistent and reliable results and save time and costs. Let’s work together to elevate your operations and achieve the highest standards in pharmaceutical production.
