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AMB Industri ABAMB Industri AB
AMB Industri ABAMB Industri AB
  • Our offer
    • Services
      • Project Management
      • Design and engineering
      • Mould filling simulation
      • Creating tools
      • Quality assurance
      • Validation and documentation
      • Measurement and testing
      • Packaging and logistics
    • Processes
      • Injection moulding
      • Metallising
      • Cleanroom production
      • Assembly
      • Lacquering
      • Sterile packaging
      • Product labelling
      • Joining
  • Market segments
    • Medtech
    • Electronics
    • Industrial Solutions
    • Functional Design
  • About
    • Company
      • AMB in a nutshell
      • Our story
    • How we work
      • Purpose, mission, vision and goals
      • Our values
      • Our 12 principles
      • Code of conduct
    • Corporate governance
      • Ownership, the board and executive management
      • Sustainable development
      • Quality and environmental management
  • AMB Academy
    • Knowledge blog
    • Seminar
    • Surface treatment school
    • Customer solutions
  • Careers
    • Work with us
    • Vacant positions
    • Students / summer jobs
    • Application
  • Press
    • Press releases
    • Image bank
    • News archive
  • Contact
    • Contact details
    • Contacts

Validation and documentation

Home ServicesValidation and documentation

Validation and documentation

What is process validation?

Process validation is a method used to ensure the results of a series of production steps that together constitute a manufacturing process. It is based on verifiable documents and data which show how product and process specifications are met.

Process validation is often required by regulatory authorities in the medical technology field. The most common processes that need validation are high-volume injection moulding and welding operations, such as those involved in sterile packagings.

Applicable in different industries

In addition to meeting statutory requirements, process validation is an excellent tool for safeguarding high-production manufacturing processes for extended periods. Because it’s a successful method for achieving acceptable costs in high-volume processes, it’s also used outside the medical technology field. There are different conventions in different industries concerning how to work with process validation. For example, the Production Part Approval Process (PPAP) method has long been used in the automotive industry.

IQ, OQ and PQ

At AMB, we use established process validation methods to safeguard our manufacturing. The basic structure for medical devices is divided into the steps IQ, OQ and PQ to verify production start, process limits, and continuous production for the steps involved in the production process. Our validation activities are documented, made available to our customers and often form part of the product’s technical file for CE marking.

For some of our customers, we use the PPAP model instead.

Equipment used for testing parts is calibrated by means of methods that are themselves subject to verification. We use documented statistical methods to determine sample sizes.

Services

  • Project Management
  • Design and engineering
  • Mould filling simulation
  • Creating tools
  • Quality assurance
  • Validation and documentation
  • Measurement and testing
  • Packaging and logistics

Processes

  • Injection moulding
  • Metallising
  • Cleanroom production
  • Lacquering
  • Assembly
  • Sterile packaging
  • Product labelling
  • Joining
AMB Logo


AMB Industri AB is specialised in injection molding and surface treatment of plastics, mainly in the medical field. We also have cleanroom production with fully automatic assembly of medical disposable items.

Our factory is located idyllically at the Lyckebyå river in the southeast of Sweden. AMB was founded in 1946 and is today family owned in the third generation.

Contact us

  • AMB Industri AB
  • Kvarnvägen 26, Broakulla, Sweden
  • +46 471 485 00
  • info@amb.se

News

  • The European medtech industry in figures 2019 April 29, 2019
  • We strengthen our organization in West Sweden April 3, 2019
  • Popular project manager is back January 18, 2019
  • What is Medical Technology? January 15, 2019

Customer solutions

  • English
    • Svenska

© 2021 — AMB Industri AB

  • Plastic parts. Refined.

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