WORKPLACE EXPERTISE:
Sterile / Non-Sterile Operations, Diagnostics, Therapeutics, BioTech, Cell & Gene Therapies, Specialty Care, Vaccines, General Medicines
HIGHLY EXPERIENCED IN:
COMMISSIONING & QUALIFICATION:
Autoclaves, SIP / CIP
Depyrogenation Tunnels / Ovens
Liquid Fill Systems
Warehouses, Cold Storage Facilities
Vial Washers, Parts Washers, Cappers, Tray Loaders
Refrigerators, Freezers, Walk-In Cold Rooms
Incubators, Stability/Environmental Chambers
Tablet Press and Coaters, Encapsulators,
Lyophilizers
Laminar Flow Hoods/Biological Safety Cabinets
Bioreactors, Plate Readers, Cell Washers
Granulation, Wet/Dry Mills, Blenders & Mixers
Sterility Test Isolators
FACILITIES/UTILITIES/SYSTEMS VALIDATION:,
Building Management Systems (Rockwell Automation, Honeywell EBI, Siemens (Insight-Desigo), Johnson Controls-Metasys)
HVAC & Automation, PLC
Laboratory Systems - HPLCs, UPLCs, MPLCs, TOCs, Spectrophotometers, Synthesizers, Conductivity
CSV, Data Integrity Resolution
Packaging / Process Validation
Process Validation, Aseptic Processing
Clean Rooms, Environmental Monitoring
Clean Compressed Air / Nitrogen/Argon Systems
Water for Injection Systems, Clean Steam and
Purified Water Systems
CLEANING VALIDATION:
Development / Validation Protocols and Reports
Residue Testing (API-Product, Detergent-Low TOC)
Statistical Sampling and Acceptance Criteria Development
Equipment Analysis of Key Contact Surfaces Areas
DECOMMISSIONING:
Qualified Equipment - Associated Instrumentation
Facilities/Utilities - Associated Instrumentation
Validated Systems (Lab Computer Systems, IT Software Systems, DCS Systems)
ANNUAL REVALIDATION:
Controlled Temperature Units, Fill Systems, Depyrogenation Tunnels/Ovens, Autoclaves, SIP/CIP Systems, Vial Washer Systems, Warehouse Seasonal Requalifications.
OUR INDUSTRY STANDARD TEST EQUIPMENT:
Kaye Validator Systems
Kaye RT (Real Time) ValProbe Systems
Kaye Standard ValProbes
Kaye LabWatch Environmental Monitoring System
Onset/HOBO Wireless Temperature/Humidity Data Loggers
CO2 Meters
Draegar Compressed Air / Nitrogen Test Kits
Multi Meters
Signal Generators
Tachometers
All of our equipment is NIST calibrated, supplied with
NIST-traceable calibration certificates.
DOCUMENTATION PRACTICES:
PLANNING:
Master Plans
GMP Critical Review
Requirements Analysis
Project Plans
REQUIREMENTS:
User Requirements
Risk Assessment
Functional/ System Specifications
Vendor Qualification
DESIGN/REVIEW:
Design Specification
Design Qualification
Build / Review
FAT & Commissioning
SOP Development
TESTING:
IQ/OQ/PQ
Verification Qualification
Document Development
Test Execution
Final Summary Reports
Requirements Traceability Matricies
PROCEDURAL:
Vendor Audits
Risk Assessments
Gap Analyses
Product Review
Change Control Programs
Technology Transfer
Periodic Review
Monitoring and Controls
