Aseptic manufacturing

Cutting edge containment solutions for aseptic manufacturing in the biopharmaceutical, life sciences and diagnostic industries

I Stock 1221576332

With rapid advances being made in Advanced Therapy Medicinal Products, or ATMPs, (medicines for human use based on genes, tissues or cells) and a frequently changing regulatory environment, those working in pharmaceutical aseptic manufacturing face an exciting and challenging period of expansion. Global growth in the use of personalised medicines means the industry has to respond to demand for faster turnaround, compliant sterile environments and cost-effective containment solutions.

Whether you're involved in small batch aseptic filling for clinical trials or late phase/commercial manufacturing of medicines in liquid vials, syringes or IV bags, operator and product protection is vital. This is especially true when handling the new generation of High Potent Active Pharmaceutical Ingredients (HPAPIs) most frequently used in oncology treatments in the form of Antibody Drug Conjugates (ADCs) as well as in hormonal drugs and glaucoma treatments.

The aseptic manufacturing market is forecast to grow to $500 billion by 2025, and those at the forefront of this growth are already capitalising on new technologies that can drive efficiencies in Grade A environments.

Mini ISO with Hatch 6

Giving you a competitive edge

Our range of isolators for aseptic manufacturing processes are designed to:

  • Allow continuous manufacturing by decreasing decontamination cycle times from 8-10 hours to just 1, when only process chambers rather than whole cleanrooms need to be cleaned
  • Deliver significant cost savings by containing processes such as incubation or centrifuges within one enclosed Grade A environment isolator system, allowing the rest of your cleanroom to remain at Grade D
  • Remain cGMP compliant, with solutions that meet the requirements of changes to Annex I

Future innovations

To minimise the risk of handling both HPAPIs and non-potent compounds further, and protect the sterility of the product throughout the manufacturing process, aseptic isolators that can be retrofitted around your existing process equipment are now available. This includes enclosing complex technologies such as robotic arms and powder dispensing systems.

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