Puretech’s project management encompasses every stage in a project’s development from conception to completion, including design, installation, commissioning validation and client training.

The project manager

Every project is assigned a dedicated project manager who provides the key point of contact and is responsible for all aspects of the contract, notably:

• Co-ordination
• Planning
• Critical path analysis
• Fast track programming
• Health and safety
• Quality assurance
• Environmental considerations
• Compliance

The project team

The project manager will, during the various stages of the contract, be supported by the other members of the Puretech team who provide specialist professional skills, including:

• Design engineers
• Process engineers
• Installation engineers
• Welding inspectors
• Project engineers
• Construction supervisors
• Commissioning engineers
• Validation managers
• Quality assurance managers
• Health and safety managers
• Environmental managers?

Puretech recognises and endorses the requirements of clients in the pharmaceutical and medical industries and their governing bodies for the strictest control of materials used and procedures employed in the installation of high purity delivery systems.

Our comprehensive understanding from over three decades of experience of industry requirements and legislation informs Puretech’s work and enables us to fully meet and exceed the required standards. Our installation engineers are highly skilled and fully trained to meet today’s needs for high integrity, high purity installations, working in accordance with relevant regulations and guidance.

Food and Drug Administration (FDA) and Medical Control Agency (MCA) protocols, including Current Good Manufacturing Practice regulations for human pharmaceuticals.

Construction Design and Management (CDM) regulations

NHS estates guidance for medical gas pipeline systems (HTM 02-01)

British Compressed Gases Association (CGA) Codes of Practice

Pressure Systems and Transportable Gas Containers Regulations 1989

We pride ourselves on innovation, approaching each project with the objective of finding the best possible solution for meeting the client’s requirement, whilst working within the parameters of existing legislation and our own high standards of good practice.

OASYS, GENYSY and Argon0 and the constituent parts for all our systems are engineered in our fully equipped UK manufacturing facility, which includes:

• Class 10 cleanroom
• Class 10,000 test and assembly area
• Degreasing facility
• CNC machinery

Our well-equipped facility  matched with our in-house engineering expertise produces a wide range of customised systems, including:

• Gas delivery systems
  • Medical gases
  • Laboratory gases
  • Toxic and corrosive gases
• Anaesthetic gas scavenging systems
• Medical and process vacuum systems
• Fuel emission analysis systems
• High purity delivery systems
  • Water for injection (WFI)
  • Purified water
  • Pure steam
  • Demineralised water
• Analytical racks
• Filter skids
• Coded vessels
• Gas control systems
• Stainless-steel manifolds
• Multi cylinder manifolds
  • Process lines
  • Clean in place (CIP) and sterilise in place (SIP)

Every Puretech installation must fulfil three key criteria. It must be on time, in budget and perfect both technically and aesthetically.

Installation capabilities

Puretech has the capability to undertake the complete process installation encompassing a wide range of materials, including:

• Degreased copper
• Stainless-steel
• Acrylonitrile Butadiene Styrene (ABS) and polypropylene
• Polyvinylidene difluoride (PVDF) and Teflon™PFA
• Hastalloy/monel/tungum

Project management

Every project has a dedicated project manager who is responsible for ensuring that the project is completed on time and in budget, negotiating all the customary challenges plus any logistical or administrative challenges specific to that project e.g. installing a system in a foreign country or accessing a building site in central London.

Every Puretech system is rigorously tested to ensure full compliance with safety, integrity and performance requirements.

Testing and analysis procedures for medical and laboratory gas systems can include:

• Pressure testing
• Anti-confusion testing
• Zone valve testing
• Non-interchange ability testing
• Terminal flow rate and pressure test
• Manifold and plant operation test
• Alarm function test
• Particulate testing

Boroscoping is used to check the pure water systems prior to commissioning.

Hydrogenation systems are tested using the Pressure Equipment Directive

(PED) standard regulations that govern this type of system.

Puretech’s in-house validation team take control of the qualification process by providing documentation to verify the design, installation and operational requirements.

The documentation package can include:

• Design specifications
• Good automated manufacturing practice (GAMP) documentation
• Weld procedures and qualifications
• Weld logs and isometric drawings
• Material certificates
• System completion certificate
• Passivation records
• As-built drawings
• Video boroscoping
• Operation and maintenance (O&M) manuals
• Testing and commissioning records
• Design qualification (DQ), installation qualification (IQ) and operational qualification (OQ) and performance qualification (PQ) protocols.