HIGHLY EXPERIENCED IN:


COMMISSIONING & QUALIFICATION:
Fluid Bed Dryers
Liquid Fill Systems
Depyrogenation Tunnels / Ovens

Autoclaves, SIP / CIP
Warehouses, Cold Storage Facilities
Vial Washers, Cappers, Tray Loaders
Refrigerators, Freezers, Walk-In Cold Rooms
Incubators, Stability/Environmental Chambers
Parts Washers
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 & Automation
HVAC (Temperature/Humidity/Pressure Control)
DCS - (Rockwell, Honeywell, Siemens, Johnson Controls)
PLC
Laboratory Systems - HPLCs, UPLCs, MPLCs, TOCs, Spectrophotometers, Synthesizers
Computer System Validation

Data Integrity Resolution
Packaging 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 ValProbes
Kaye RF 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