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What We Do At Andersen Caledonia

Andersen Caledonia provides a wide range of infection control based services to support the manufacture and use of medical devices. In addition Andersen Caledonia provides testing to support environmental control programs within the healthcare industry and the wider community.

Key services offered include

  • Ethylene oxide sterilisation for large or small volumes
  • Steam sterilisation using a variety of cycles
  • Cleanroom packing and assembly of medical devices, surgical packs and other goods to be used as sterile
  • Laboratory testing to support the manufacture and use of sterile medical devices
  • Environmental monitoring of cleanrooms and other controlled areas
  • Provision of consumables and tests to support hospitals' sterile processing functions
  • Water Testing for a variety of microbiological and chemical tests including Legionella, drinking water analysis, hospital monitoring, environmental monitoring and swimming pool monitioring.

Andersen Caledonia supports a large customer base from across the UK and the rest of the world. Our customers include hospitals, medical device manufacturers, pharmaceutical manufacturers, local councils and research organisations. While we supply many large multinationals we also provide a high degree of service to small or start-up companies. Our company is based around a flexible approach to production allowing us to handle small batches or orders quickly and efficiently.   

The company has two large ethylene oxide sterilisation chambers and one steam sterilisation chamber. This allows us to process large volumes of product quickly and cost effectively. We run both dedicated sterilisation cycles and mixed load cycles. For customers wishing to sterilize a load using ethylene oxide or steam sterilisation rapidly we offer an express service for an additional fee.

Andersen Caledonia's Services Include:

  • Ethylene oxide sterilisation / sterilization using vacuum sterilisation chambers.
  • Ethylene oxide validation in accordance with ISO11135
  • Ethylene oxide gas residual testing in accordance with ISO10993-5
  • Steam sterilisation in accordance with ISO17665
  • Sterile Packing validation in accordance with ISO 11607 and AAMI including accelerated aging
  • Sterile Packing of medical devices and packs in a cleanroom
  • Assembly of medical devices in a cleanroom
  • Bioburden Testing in accordance with ISO11737 -1
  • Sterility Test in accordance with ISO11737 -2
  • Endotoxin / LAL testing using turbidimetric or gel clot method in accordance with ISO10993, EP, USP, CFPP & HTM
  • Water Testing for Total Viable Count (TVC) - ISO 15883, CFPP & HTM 2030 
  • ISO 15883, CFPP & HTM 2030 Water testing for Mycobacteria Water
  • Testing for Legionella Water
  • Testing for Potable Water - TVC at 22oC, 37oC, Coliforms/E Coli - Microbiology of drinking water part 4 & 7
  • Liquid Particulate Analysis
  • Chemical Analysis of Water
  • Clean Steam Testing HTM 2031 and EN 285
  • Cleanroom Monitoring in accordance with ISO 14644 & ISO 14698
  • Validation of reuse instructions for medical devices in accordance with ISO 17664, ISO15883, CFPP, HTM
  • Supply of consumables for ISO 15883, CFPP & HTM 2030 Testing including test soil, biofilms and surrogates
  • Supply of sterile bottles
  • Swimming Pool water analysis
  • Pseudomonas testing of water

We also offer additional tests as requested.

Certifications Inverted banner

To view our extensive range of certifications and accreditations click above. 

Andersen Caledonia Marketplace:

surgkits logo

  • Instrument Packs
  • Dressing Packs
  • Single Use Instruments

Test water logo for water testing supplies

  • Test Soils
  • Water Testing
  • Sterile Bottles

About Andersen Caledonia

Andersen Caledonia was founded in 1998 by Lauren Andersen and Jonathan Lintott in Bellshill, Lanarkshire and has grown organically in every year since. We now work with more than 250 medical device manufacturers, hospital trusts, pharmaceutical suppliers and other companies involved in the healthcare and water industry.

Andersen Caledonia’s focus from start up has been to offer a service that meets the requirements of the regulatory agencies on a global basis. As well as being an ISO13485 manufacturer, the company’s laboratory is UKAS accredited to ISO17025 and is  MHRA approved for microbial monitoring of controlled environments.

Mission Statement

We aim:

  • To provide an unparalleled level of service and a high level of care to every customer no matter the size or location.
  • To have an honest and hard-working face to our company, always available on the phone to help you.
  • To have a fast turnaround to any order with a completely transparent system of dealing with your products, so you know exactly where they are and when you will have them back.
  • To provide the highest level of sterility for your products at the lowest cost. The flexibility of ETO allows us to cater to almost any product material and shape so that you can be secure in sending your products to hospitals around the world.
  • To provide a comprehensive system of regulatory support with a customer focussed approach.

Contact

Caledonian House,
Phoenix Crescent
Strathclyde Business Park
Bellshill, North Lanarkshire
Scotland, UK
ML4 3NJ

Tel:  01698 844 476
Fax: 01698 844 481

Certifications

ISO 9001 with UKAS certificateISO 13485 with UKAS certificateUKAS 4147 accreditation logo