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We perform autoclave validation
and autoclave requalification to HTM 2010,
EN 285, EN 554, PDA Monograph and ISO standards. This validation work
is often performed to tight timescales fitting in with production
requirements and autoclave availability.
We aim to reduce
both the time and the cost by:
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Individually
developed, application specific protocols
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Work scheduling to meet production needs
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Prompt delivery of reports and raw data
We can provide a range of
services from delivering a full validation package,
including the development of procedures, protocols
and related documentation to simple
implementation of existing client procedures.
Typically, our service will involve on and
off-site work, regular performance reviews and on-going support for
Continuous Compliance Assurance which ensures the sterilisation process
is in a continual state of inspection readiness.
Our lifecycle validation service includes:
We ensure quality throughout the work by strict adherence to
procedures and protocols and by deploying highly trained and competent
staff.
Our autoclave
validation and requalification services have been carried out on Getinge/SEC, Fedegari, Steris/Finn-Aqua, SAL, De-Lama, ICOS, Huber, British Steriliser
and many other autoclave manufacturers. Cycle Development for Porous and Fluids
Load Autoclaves
Cycle development delivers the most efficient, robust cycle for
production availability, regulatory compliance and reduced
re-qualification effort in the future.
Cycle development, done properly, saves time and money during PQ and
ongoing production:
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Porous Load Equilibration time requirements met
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Load Dryness for Aseptic Processing
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The most efficient overall cycle time delivered
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Fluids loads optimised based upon bioburden data
Specific HTM 2010 and EN285 Benchmark Testing performed as part
of OQ testing
Our in-depth understanding of the HTM 2010 and EN285 standards ensures delivery of
compliance and reliability in the future.
Control System Validation, Supplier Auditing and
Validation Files
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Application of GAMP 4 requirements to Autoclave
Control Systems
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21CFR part 11 compliance for autoclave cycle data and validation
data
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KAYE Validator 2000
equipment used as standard
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Control System audits and upgrades
PQ Testing
Proper cycle development will deliver efficient PQ with fewer failures
and more robust results
Other Processes Validated
We offer validation services for a wide range of pharmaceutical
processes and equipment. Our specialist areas include:
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