Disposable Systems by Pall Life Sciences Products - Biopharmaceutical Division

Managing the issues of cleaning and cleaning validation is one of the major challenges facing the BioPharmaceutical industry. This has resulted in the use of disposable equipment being the preferred option wherever possible. Using disposable equipment offers many benefits.

Features and Benefits

• Reduced assembly costs
• Reduced cleaning costs
• Reduced cleaning validation
• Reduced costs for capital equipment - capsule filters have a typical installation cost that is 80% lower than a similar sized stainless steel housing system
• Reduced risk of lost production time due to simpler procedures

In applications where hazardous materials are being processed, such as cytotoxic drugs, disposable equipment can play an important additional role in helping protect operators. Hazardous liquids can be contained during processing with minimal risk of operator exposure.

Choice and Flexibility
Pall supplies a wide range of disposable filter assemblies and disposable filtration sets, such as capsule filters with customized tubing systems attached. Pall also supports the use of filters attached to disposable bag based processing systems. Disposable capsule filters of all sizes with surface areas from a few cm2 to as much as 4.8 m2 (50 ft2) are available and can be used in disposable systems. Filters join together in series for protection of the final filter or in parallel for increased area, making it possible to have unlimited filtration area in disposable systems.

Flexibility of system design facilitates changes in product to process development.

Made from a range of materials such as:

• PES (polyethersulfone)
• PVDF (polyvinylidenedifluoride)
• Nylon 66
• PTFE (polytetrafluoroethylene)
• Polypropylene
• Resin-bonded glass fiber
• Cellulose-based depth media
• Scaling Up and Scaling Down

Pall is well-equipped to support processes as they are scaled up. Different size capsules for each specific Pall filter grade contain identical filter materials. This feature ensures that scale-up and scale-down studies yield relevant information and minimum requalification for various batch sizes.

The availability of a variety of capsules for small scale operations is beneficial, particularly for new product developments. Capital investment can be a concern since not all new BioPharmaceutical products become commercialized. Single-use capsules and systems make it possible to produce new products during the early development stages, without a large capital investment. Capital deferment and risk avoidance make it easy to produce test batches for early clinical trials and toxicity studies without capital equipment.