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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 |


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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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| ©
Copyright Hanley Validation Services 2004 |
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