Biologics, Sterile Manufacturing, Medical Devices

Biologics, Sterile Manufacturing, Medical Devices

For protection and strict standards in aseptic processing cleanrooms, turn to Camfil for air filtration solutions for the biopharmaceutical and medical devices industries.

Without air filters, we wouldn’t be able to safely manufacture medical devices, vaccines, gene therapies, highly potent drugs and other life-critical pharmaceutical products. Strict requirements and regulations define cleanliness levels. And it’s no wonder – after all, airborne contamination directly impacts the quality of pharmaceutical products and medical devices.

 

Hi-tech and biotech need the cleanest air possible

Manufacturing biological drugs (biologics) is a unique and complex process. Biologics are made from proteins from living organisms that have been engineered to produce therapeutic proteins in large quantities. They are extremely sensitive and can be negatively affected by even the slightest process change.

Similarly high requirements exist for medical devices that are used in critical situations. They are subject to strict regulations, so their manufacture requires cleanrooms to ensure that they meet these regulations. 

Filling pharmaceuticals is a highly critical process that requires a completely clean and controlled environment. Filtration systems help to maintain cleanliness levels throughout the different process zones, from grade A to grade C or D. In all these situations, the direction of the airflow needs to be controlled to prevent any cross contamination from infiltrating the final product.

Different aseptic processing areas have different requirements

Aseptic processing facilities require different air filtration solutions for each of these areas:

 

Area

Solution

MAU and AHU

Wash and prep

Depyrogenation tunnels and sterile preparation rooms

High-end pre-filtration for minimising total cost of ownership and protecting critical areas

 

Efficient HEPA filter systems for smooth cleanroom operations – Camfil CleanSeal™ and Megalam™

 

Increase depyrogenation tunnel throughput with Absolute D-Pyro, the most efficient high-temperature filter on the market

 

Aseptic filling

Mini-environments like restricted access barrier systems (RABS) and isolators

Megalam and push-push filters for work environment protection

 

CamSafe™ range to protect workers and the environment

Packing areas

CamCleaner™ for maintaining a clean, safe warehouse

 

Gain peace of mind for all your sensitive processes

Camfil is a leader in air filtration solutions for the life science industry and works in close cooperation with several of the largest global pharma manufacturers. We offer filters, housings and air cleaners designed to comply with strict demands on safety, traceability and control.

Our complete range of ProSafe™ filters for medical and sterile manufacturing offers these benefits:

  • Specially developed for process safety in medical and sterile manufacturing environments
  • Inert to microbial growth and contamination in accordance with ISO 846
  • Most energy-efficient filters – their high quality does not compromise operational efficiency
  • Tested resistance to chemicals used for cleaning and decontamination in cleanrooms
  • Free of harmful chemical components such as formaldehyde, phthalates and bisphenol-A
  • Sturdy and resistant to moisture and corrosion for a hygienic HVAC system in accordance with VDI 6022

Camfil’s CleanSeal™ filter housing is also specially designed for life sciences. It is a robust, fully welded, leak-proof solution that is easy to install, handle and maintain.

Benefits of Camfil air filtration solutions

Control your sensitive production environment with dedicated air filtration solutions for aseptic environments. You will gain these overall benefits:

  • Protect your products from contamination and cross contamination, ensuring product quality
  • Minimise product rejects and liability
  • Prevent employees from coming into contact with biological matter
  • Protect the environment by ensuring the relevant biosafety levels
  • Comply with strict environmental and workplace regulations
  • Minimise operational costs with energy-efficient filter performance
  • Perform easy, safe filter changes with minimal disruption to operations and no risk of contamination