Services
What we do:
Being a “niche” company, we provide specialized services for a very serious industry. We do not claim to know and do it all. We are a dense group of highly experienced professionals that are experts in our given subject areas. This deliberate stance is our greatest attribute and translates into direct and
fast turn-around results for our clients.
WE ARE HIGHLY EXPERIENCED IN:
Being a “niche” company, we provide specialized services for a very serious industry. We do not claim to know and do it all. We are a dense group of highly experienced professionals that are experts in our given subject areas. This deliberate stance is our greatest attribute and translates into direct and
fast turn-around results for our clients.
WE ARE HIGHLY EXPERIENCED IN:
EQUIPMENT COMMISSIONING & QUALIFICATION:
o Fluid Bed Dryers
o Liquid Fill Systems
o Depyrogenation Tunnels / Ovens
o Autoclaves
o SIP / CIP
o Vial Washers, Cappers, Tray Loaders
o Refrigerators, Freezers, Walk-In Cold Rooms
o Incubators, Stability / Environmental Chambers
o Parts Washers
o Tablet Press and Coaters
o Encapsulators
o Lyophilizers
o Laminar Flow Hoods
o Reactors
o Granulation, Wet/Dry Mills, Blenders & Mixers
o Sterility Test Isolators
FACILITIES / UTILITIES / SYSTEMS VALIDATION:
o Building Management & Automation
o HVAC (Temperature/Humidity/Pressure Control)
o DCS - (Rockwell, Honeywell, Siemens, Johnson Controls)
o PLC
o Data Integrity Resolution
o Laboratory - HPLCs, TOCs
o Computer System Validation
o Packaging Validation
o Process Validation
o Aseptic Processing
o Clean Rooms
o Clean Compressed Air / Nitrogen Systems
o Water for Injection Systems
o Purified Water Systems
CLEANING VALIDATION:
o Validation Protocol and Report Development
o Microbial Testing
o Residue Testing (API-Product, Detergent-Low TOC)
o Statistical Sampling and Acceptance Criteria Development
o Equipment Analysis of Key Contact Surfaces Areas
DECOMMISSIONING:
o Qualified Equipment - Associated Instrumentation
o Facilities/Utilities - Associated Instrumentation
o Validated Systems (Lab Computer Systems, IT Software Systems, DCS Systems)
ANNUAL REVALIDATION:
o Fill Systems
o Depyrogenation Tunnels / Ovens
o Autoclaves
o SIP / CIP Systems
o Vial Washer Systems
o Warehouse Revalidations
WE OWN AND CARRY AN EXTENSIVE INVENTORY OF INDUSTRY STANDARD
MEASURING / TEST EQUIPMENT:
o Fluid Bed Dryers
o Liquid Fill Systems
o Depyrogenation Tunnels / Ovens
o Autoclaves
o SIP / CIP
o Vial Washers, Cappers, Tray Loaders
o Refrigerators, Freezers, Walk-In Cold Rooms
o Incubators, Stability / Environmental Chambers
o Parts Washers
o Tablet Press and Coaters
o Encapsulators
o Lyophilizers
o Laminar Flow Hoods
o Reactors
o Granulation, Wet/Dry Mills, Blenders & Mixers
o Sterility Test Isolators
FACILITIES / UTILITIES / SYSTEMS VALIDATION:
o Building Management & Automation
o HVAC (Temperature/Humidity/Pressure Control)
o DCS - (Rockwell, Honeywell, Siemens, Johnson Controls)
o PLC
o Data Integrity Resolution
o Laboratory - HPLCs, TOCs
o Computer System Validation
o Packaging Validation
o Process Validation
o Aseptic Processing
o Clean Rooms
o Clean Compressed Air / Nitrogen Systems
o Water for Injection Systems
o Purified Water Systems
CLEANING VALIDATION:
o Validation Protocol and Report Development
o Microbial Testing
o Residue Testing (API-Product, Detergent-Low TOC)
o Statistical Sampling and Acceptance Criteria Development
o Equipment Analysis of Key Contact Surfaces Areas
DECOMMISSIONING:
o Qualified Equipment - Associated Instrumentation
o Facilities/Utilities - Associated Instrumentation
o Validated Systems (Lab Computer Systems, IT Software Systems, DCS Systems)
ANNUAL REVALIDATION:
o Fill Systems
o Depyrogenation Tunnels / Ovens
o Autoclaves
o SIP / CIP Systems
o Vial Washer Systems
o Warehouse Revalidations
WE OWN AND CARRY AN EXTENSIVE INVENTORY OF INDUSTRY STANDARD
MEASURING / TEST EQUIPMENT:
- Kaye Validator 3 Systems
- Kaye ValProbes
- Kaye RF ValProbes
- Kaye LabWatch LTE Environmental Monitoring System
- Various Wireless Temperature and Humidity Data Loggers
- CO2 Meters
- Compressed Air Test Kits
- Multi Meters
- Signal Generators
- Tachometers
All calibrated and supplied with NIST-traceable certificates.
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OUR DOCUMENTATION PRACTICES:
PLANNING:
• Master Plans
• GMP Critical Review
• Requirements Analysis
• Project Plans
REQUIREMENTS:
• User Requirements
• Risk Assessment
• Functional/ System Specification
• 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
PLANNING:
• Master Plans
• GMP Critical Review
• Requirements Analysis
• Project Plans
REQUIREMENTS:
• User Requirements
• Risk Assessment
• Functional/ System Specification
• 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
