The necessity for Sterility Testing Barrier Isolators

Pharmacopoeias require the Sterility testing of sterile pharmaceutical products to determine acceptability of a production batch. Sterility Testing is therefore an essential element of sterilization validation.

Barrier isolators are therefore imperative to ensure the product confirms to these essential regulations by elimination of contamination from the process and the environment.

Standard Group of Companies Sterility Test Barrier Isolators are designed to allow operators to perform sterility testing in an aseptic environment providing assurance of process integrity.

This perfect parameter monitoring will enable: -

• Full Traceability
• Full adherence quality product
• Efficient sterility testing.

The barrier isolator will also provide a controlled means of loading and removing the processed product and waste materials from the isolator enclosure.

If you do not use a Barrier Isolator, in some cases this can cost you money in the region of: -

$30k – $300k / year

This is due to: -

• Delayed product release
• Increased quarantine time
• Investigations required
• Cost & Time of Investigation
• Destroy “Good” Product
• Lost Sales

Further Advantages of a Sterility Testing Barrier isolator: -

• Virtually No Sterility False Positives.

• Ability to maintain sterility of equipment over a period of time. No gowning required.
• Less expensive to operate versus clean room
• Integrates with 3rd party filling lines.
• Adheres to regulatory standards.
• Reduced risk of human intervenion.
• Improves filling line operation/performance.

The Standard Group of Companies will provide you with a Turnkey solution which will support all of your sterility testing activities.

This includes: -

• URS
  • Design
• Manufacture
• Commissioning and installation
  • FAT
  • SAT
  • IQ
  • OQ
  • PQ

The Standard Group of Companies will also off "Value added services" which includes:-

• Complete overhaul of in-field isolators

If you need any more information please contact our offices in India or the UK.

The contact details are on our website.

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