Liquid Borne Particle Counting
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With PMS Rubidium Laser Counter to USP XXII for LVP's
and SVP's plus B.P., Ph. Eur., plus individual client requirements from
2 microns to 150+ microns. |
Heat Sterilization Process Validation
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Use our Kaye Instruments Portable Validator and Intelligent
Probe with client owned calibrated Thermocouples (any type) or PT-100's
for your original OQ and PQ and for requalification |
Sterilization Process Optimization and Equipment Selection
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Training
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Complete CGMP and QA training courses for pharmaceutical, medical device
and biotechnology industries. Courses can be company specific or general.
Training programmes specific to individual companies with in-house modules. |
Facility Design
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Assistance with facility design for CGMP and QC technology to optimise
production and profitability. Liaison with architects and constructional
engineers in design requirements for production, laboratory and research
facilities. |
Process Validation
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Sterile and non-sterile product manufacture. Medical device manufacture.
Bulk pharmaceutical chemical manufacture. HVAC, water systems, production
and distribution. Environmental contamination, cross contamination. Viable
and non-viable particulate counting. |
Documentation Systems
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Design, provision and implementation of documentation systems, including
SOP's sampling plans and analytical techniques to UK DoH and US FDA requirements.
Existing system review for change control measures. Trend analyses and
internal audit systems. Labelling. |
Regulatory Activities
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Audits for compliance with international CGMP's and QA systems. Audits
for GLP's and all documentation systems. Recall procedures. UK and FDA
licensing requirements for pharmaceuticals, medical devices and BPC's.
European community qualified person services. |
Manufacturing Reviews
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Production and QA/QC systems. R and D systems. Manufacturing processes.
Equipment selection reviews for production and QA/QC.
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Laboratory Testing
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Sterility testing to DoH and FDA standards. Antibiotic assay to all
major regulatory requirements. Total viable counts and particulate counts.
Microbial identification. HEPA filter certification to FED STD 209 and
BS 5295 requirements. Other laboratory testing on request.
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Lyophilization
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Differential thermal analysis on new or existing formulations. Training
course on lyophilization, equipment purchase and comparison, and validation
of lyophilization processes.
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