Sterility Assurance at every step of the way
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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.