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





Our Services