Hanley Validation Services Commissioning Validation & Compliance Services
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Hanley Validation Services offers a full-range of Validation, Commissioning and Regulatory Compliance services for your cGMP/GLP facility

HVS is adept at integrating validation and commissioning with the engineering and construction phases of a project.

By integrating validation and commissioning into the overall project, HVS can complete the validation effort quicker than traditional approaches.

HVS can provide true start-up and commissioning services to ensure that all systems are correctly installed and in proper order prior to formal qualification.


Validation

- Preliminary Validation Planning - Critical Utility Qualification
- Validation Master Plan Development - Equipment Qualification
- Protocol Development and Execution IQ,OQ,PQ - Analytical Equipment Qualification
- SOP Development - Computer Systems Validation
- Final Report Development - Process Validation
- Validation of Computer Systems - Cleaning Validation
- Validation of higher level systems including LIMS and ERP - Facility Qualification
- Retrospective Validation - Training Programs




Commissioning

- Vendor Auditing - Commissioning Test Plan Development.
- Construction Dossier/Equipment File Reviews - System walkdowns and punch list generation
- Pre delivery Inspections - Commissioning Execution
- Factory Acceptance Testing - Summary Report Development





Compliance

- GMP Auditing - GMP / Validation Training Courses
- GMP Document Reviews - System Criticality Assessment

 


EXPERIENCE

HVS can unlock the solutions to the common staffing, experience, schedule, and budget challenges we all face.

For new installations and facilities, we can perform commissioning and validation activities concurrent with construction, enabling production activities to commence much sooner.

For newer companies or departments, we can assist you in establishing protocol formats and content with a history of meeting US and EU regulatory expectations.

For established companies, we can easily adapt to your established format.

In all cases, our combination of experience and flexibility is designed to meet your needs

Equipment and Systems Experience


Equipment:

- Reactors - Incubators
- Crystallisers - Inspection Systems
- Hydrogenators - Lyopholizers
- Dryers - Cell Culture Bio reactors
- Centrifuges - IBC Blenders
- Fluid Bed Dryers - IBC Wash Stations
- Freezers - Mixers
- Cappers - Ovens
- Depyrogenation Tunnels - Refrigerators
- Encapsulators - Storage Chambers
- High Intensity Granulators - High Speed Tablet Presses
- Vessels - Filtration Systems (MF, UF, TFF)
- Tunnels - Glassware Washers
- Fermenters - Glove Boxes
- Fillers - Fume Hoods
- Compendial Water Systems - Clean Steam Generators
- Critical Gas Systems - Fixed and Mobile Sanitary Process Vessels



Utility Systems:

- Compendial Water Systems (Purified Water USP/EP, WFI USP/EP) - Critical Gas Systems (Process Air, Nitrogen, Oxygen, Carbon Dioxide)
- Non Compendial Water Systems (DI, Ro, UF) - Vacuum Systems
- HVAC Systems - Heat Transfer Systems (Glycol, Dow Therm, Methanol)
- Clean Steam Systems - Chilled & Potable Water Systems
- Plant Steam Systems - Emergency Relief Systems
- Scrubber Systems - Electrical Systems. (Direct On Line & UPS)



Laboratory Systems:

- Laminar Air Flow Booths - GCs / HPLCs
- Centrifuges - Micro-plate readers
- Chemical weigh and dispensing systems - Scales
- Dryers - LIMS


 
Cork: Technology House, Wallingstown, Little Island, Cork Tel: +353 21 4520220 Fax: + 353 21 4520221
Dublin: Unit 15 Westport Business Park, Mulhuddart, Dublin 15. Tel: +353 01 8204445 Fax: +353 01 8211233
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