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Cycle Development

Cycle Development

Experience counts

Air Detectors

Air Detectors

Superior process control for porous load sterilisers

Autoclave Thermal Qualification

Autoclave Thermal Qualification

Temperature mapping of autoclaves and sterilizers

Consumables

Consumables

Sterilization Validation Consumables

Biological Indicators

Biological Indicators

Leaders in the use and analysis of BI's

Support & Maintenance

Support & Maintenance

With you at every step of your process

Sterilisation Validation

We have extensive experience designing sterilisation approaches using the overkill approach, and product specific approach using Biological Indicator (BI) Bioburden methodology for finished pharmaceuticals and medical devices as regulated by MHRA, HPRA and FDA.

We have conducted training in and assisted autoclave manufactures to meet the requirements of EN285 - Large Sterilisers.

Our expertise supports clients during the initial stages of the URS (User Requirement Specification), all the way through to IQ, OQ and PQ, as well as delivering on-going re-qualification of:

Autoclave sterilisers, Incubators, Lyophiliser freeze dryers, Depyrogenation tunnels, Steam in Place (SIP) applications, Active temperature controlled systems (fridges, freezers, cold rooms) and Dry heat ovens in accordance with ISO 20857.

We understand that downtime and asset utilisation are extremely important to you so pride ourselves in offering:

  • Reduced downtime through utilisation of modern technologies and expert knowledge
  • Increased production capacity through development of robust autoclave cycles, reducing unnecessary downtime
  • Faster turnaround time through expedited documentation service
  • In-house laboratory offering analysis on biological indicators (BI), reducing PQ validation time
  • Reduced workload, with optional Honeyman QA review of validation documentation service

To discuss your validation requirements, please contact us with your details and a brief introduction, so we can arrange a call back at a time convenient to you. 

Our Customers:

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