Pharmaceutical manufacturers have, without a doubt, seen a massive boom in demand within the past two years stemming from the COVID-19 pandemic.
In particular, the aseptic pharma manufacturing industry faces growing and unprecedented challenges exacerbated by rapid sterile vaccine development. And with the continued need for vaccines and boosters, these challenges don’t seem to be stopping anytime soon.
Addressing these challenges means finding new avenues for efficiency and flexibility while still ensuring sterility throughout the entire manufacturing process. This, in turn, has pushed several trending ideas and considerations to the forefront of pharma manufacturers’ minds.
Here are four sterile manufacturing trends we expect to dominate the pharma industry in 2022 and beyond.
1. Single-Use Technology
A significant sterile manufacturing trend is the increasing use of single-use technology (SUT), which is a piece of technology intended for one-time use.
Examples of SUT include:
- Syringes
- Tubing
- Capsule filters
- Bioreactors
- Sampling receptacles
- And more
Due to its single-use nature, SUT doesn’t need to go through the sterilization and cleaning process required with other non-single-use technology. Eliminating this process creates room for more efficiency, decreases operational and manufacturing costs, and improves controls.
Ultimately, improving your controls helps assure sterility and reduce the chance of product batch rejection.
More on single-use technologies:
2. Split Butterfly Valve Usage
The split butterfly valve (SBV) is a SUT that’s become particularly popular for pharma manufacturers. This technology allows products to safely move from one vessel to another while maintaining sterility throughout the entire process.
The SBV gets its name from its design, which features two halves – one active and one passive unit. The passive half connects to a filling container, and the active half connects to the production line equipment. Products move through these lines without coming into contact with the outside environment, thus ensuring sterility.
Containment Split Butterfly Valve from ChargePoint Technology
3. Transportation Considerations
Within the past two years, outsourcing manufacturing has become more prevalent. This has led manufacturers to scrutinize how they transfer their product from one facility or area to another and determine how they can ensure that sterility stays intact throughout.
Once again, SUT is a common solution in this case. Some companies utilize single-use bags to ensure sterility before and during transportation. Once their product arrives at its destination, these bags are discarded and, if executed properly, sterility is maintained.
4. Increased SUT Training
The massive spike in SUT usage has created a shortage of employees trained in the installation, handling, and disposal of these technologies. Having trained personnel is essential when dealing with sterile products. If an inexperienced employee improperly handles a SUT, this could lead to a compromised product.
This gap in SUT knowledge needs to be closed in a quick and scalable manner to not only ensure sterility but to stay compliant with good manufacturing practices (GMP).
Ensure Sterility in Your Pharma Manufacturing
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