Investing In the Right Equipment for Tech Transfer Excellence
Tech transfer excellence does not solely rely on the people involved. Another component is the equipment and technology that support the people and processes. Let’s look at the equipment and technology that achieves tech transfer excellence.
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Single-use technology
- Single-use technology makes a difference in supporting small to large batches at various temperatures. It is easy to use, makes products scalable, and eliminates the need for cleaning validation that could otherwise slow down timelines. Single-use technology fits platform processes and brings familiarity to the team working on multiple projects, another benefit for sterility requirements.
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Redundant filling lines
- Multiple filling lines developed by the same equipment manufacturers with the same platform technology reduce the risks of unplanned downtime. Thanks to similar technology, operators are more familiar with each line, allowing for an even better understanding of the equipment and flexibility to shift schedules. Capacity planning is improved, and timelines are further reduced when change parts qualified for ISO commodities are onsite.
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Dual filling technologies
- Equipment flexibility increases when you have the option to choose the rotary piston or the peristaltic pump for filling activities. This allows for customization based on client-specific needs and opens the door to more product capabilities.
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Using ISO Container and Ready to Use (RTU) Closures
- Using standardized containers removes the need for requalification of the fill line and possibly costly change parts with long lead times. Newer filling lines will already be set to manufacturing a wide range of ISO vials, reducing the time to manufacture. Selecting closures in ready-to-use formats and making them available in ported bags ready to dock with the latest isolator technology can reduce the potential need to qualify sterilization processes, which will add time to your tech transfer.
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Pre-prepared buffers
- Pre-prepared buffers (e.g., histamine buffers) make timelines even quicker and provide greater specificity for the client’s product. Clients can send buffers to a CDMO, like Grand River Aseptic Manufacturing, to combine buffers with products faster.
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Diverse inspection technologies
- Investing in manual, semi-automated, and fully automated inspection capabilities helps CDMOs stand out and allows all different types of products to be inspected accurately. Grand River Aseptic Manufacturing utilizes all three types of inspection: manual, semi-automated, and fully automated inspection. All our recipes for semi-automated and fully automated inspection are tied back to manual visual inspection detection data. Recipes on those systems can only be utilized if the recipe is proven to detect defects equal to or better than those in manual visual inspection. Unique inspection technologies are also used to verify container closure integrity (CCI), which supports Annex 1 guidelines. Fully automated vial inspection equipment has a feature for CCI verification utilizing high-voltage leak detection (HVLD). The newest automated inspection machines for vials and syringes can use artificial intelligence to refine the recipe for better defect detection and mitigate false rejects.