Bioprocessing bags are a flexible and customizable solution used for the safe handling of liquids within a bioprocess environment. Bioprocessing bags are used from small-scale research through to full-scale production.

They are made from a multilayer film which offers biocompatibility, chemical compatibility, barrier and strength properties, to ensure the media is handled safely.

Single-use assemblies for fluid transfer are an essential, yet often overlooked, element of modern bio manufacturing processes. Tubing assemblies are critical for transfers between single-use and hybrid systems and between cleanroom or isolator walls.

We understand the importance of hose & tubing within the biopharmaceutical process environment. Which is why we focus on the very best, market-leading portfolio of hose & tubing solutions. Sercotech can offer a solution for a wide range of fluid transfer and pumping applications. Whether your criterion is long pump life, ultra-purity or chemical resistance, we can help.

Sterile Connectors or Aseptic Connectors provide a true sterile connection within your process, even outside of the clean room environment. We can provide a wide range of options to fit all connections, offering a perfect solution to suit your process requirements.

Filtration is the most commonly used technique for separating organic material and culture filtrate. In downstream processing, the filtration step separates solids, usually cells, from the liquid growth medium. Other forms of separation include centrifugation and flocculation. Sterile filtration is used at several stages of the harvest process and for the preparation of other processing fluids (purified water, buffers, sanitizing agents, etc.) Since single-use filtration systems can be automated easily, they are widely used by bio manufacturers around the world to enhance production efficiency and performance.

• Depth
• Hollow Fiber
• Absolute
• Plate frame
• Ultrafiltration/diafiltration
• Tangential (TFF)
• Surface
• Centrifugal
• Rotary drum
• Vacuum
• Membrane

Pharmaceutical industries use compressed gases in a wide range of applications including chemical synthesis, controlled atmosphere and blanketing, cell cultivation, chilling /freezing, etc.

Gases used for human healthcare are strictly controlled by both legislation and industrial standards so as to not impair human physiology. Gases of this nature may be manufactured as pure gases or as compounds, but are always filtered to the highest quality possible. The application of each individual gas determines its production and distribution.

Cleanroom garments: 

Cleanroom disinfectants: The choice of a disinfectant is critical for a pharmaceutical cleanroom not only because of potential losses due to contaminated product but also because of user safety as well as room turnaround. Biocides used in cleanrooms are subject to FDA and USP guidelines, which classify them, describe their mechanism of action and efficiency to get the disinfection process validated.

Cleanroom mops/wipes:

Pharmaceutical mopping systems need to be effective at removing both non-viable and viable contamination, capable of applying a disinfectant or detergent, suitable for autoclaving or sterilization. If a poor choice of mop is made which is difficult or uncomfortable to use and quickly leads to operator fatigue, then a robust bio-decontamination program will not be achieved.

The lubricants used in the manufacture of pharmaceutical products and pharmaceutical packaging must be food approved. To make manufacturing processes more reliable, H1 lubricants should be used exclusively. The allowable lubricant contamination constituted by the FDA is 10 parts per million.

Cleanroom Disposable Gloves:

Cleanroom disposable gloves are ISO- and FED STD 209E-rated and have been processed to kill microorganisms to eliminate contaminants and reduce the risk of contamination and infection. Cleanroom gloves do not have a powder coating inside the glove, reducing the risk of surface contamination and allergic reactions. Disposable gloves are discarded after one use to prevent cross-contamination.

Isolator Gloves:

In the Pharmaceutical Industry, certain drugs or substances require careful handling as they may react with the outside environment or cause a threat to the operator and environment. Isolators act as a barrier between the operator area & pharmaceutical process area. Additionally, the installed glove ports make it easy to carry out manual work.

The Gloves are an excellent tool to minimize human intervention. However, even the tiniest opening in gloves can contaminate the product or be hazardous to the operator.

Selecting of suitable gloves and routine testing for integrity and sterility is an important procedure shall be considered for a safe production.