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UK: +44(0)113 3505 694 IRL: +353(0)53 9163033
UK: +44(0)113 3505 694 IRL: +353(0)53 9163033

GMP Design, Quality & Validation

GMP COMPLIANT DESIGN

We work closely with our client project teams so that we design and build a system that meets their requirements, following a Risk Managed Project Management philosophy.

We specialise in large scale projects where Tekpak machinery has to be integrated with OEM equipment to form full packaging lines.

  • GMP Design Philosophy
  • Designed so that there is no negative impact on product quality
  • Designed for ease of cleaning with smooth surfaces and crevasses minimised, no ‘dead zone’s for hidden product or materials.
  • Design philosophy is based around Pharmaceutical Industry Standards
  • Designed in accordance with User Specified Requirements

Validation
Documentation

We can offer Validation Documentation Packages to suit the requirement, including:

  • Quality Plan & Schedule
  • DQ/FMEA
  • Design Specifications (Functional/Hardware/Software)
  • IQ/OQ Test Sheets
  • FAT Protocol
  • SAT Protocol

FULL LINE FAT

We know how much effort and time goes in to a smooth installation. For Multinational Pharma Companies, based in Ireland, Tekpak offer the facilities and expertise to integrate full packaging lines with Tekpak equipment and Other Equipment manufacturers Equipment at our facility in Wexford.

 

Services Offered:

  • Management of mechanical interface (product transfers, guiding) for complete line
  • Line interface plan/process flow
  • Cascade Line Stop/Start
  • Co-ordination of samples for design evaluation & F.A.T
  • Materials handling
  • Full line installation and commissioning support with OEM partners

Benefits:

  • The critical integration of the full line can be completed away from the client site first before it is brought to the final production facility which reduces risks and

ramp- up time.

  • Costs are reduced by having all of the Vendor teams in one place.
  • Operator training can be carried out in advance of the equipment being delivered to site so reduced dependence on Vendors to support during commissioning and validation.

Facilities:

  • 20,000 sq Ft Full Line Testing Zone, which is divided in to 3 Test suites.
  • Segregation of each test suite for purpose of protecting I.P.
  • Facilities to cater for visiting Project teams and Technicians.

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