Medical Device Testing- Microbiologcal and Biocompatibility

(Bellshill, Lanarkshire and Dunston, Staffordshire)

Andersen Caledonia operates two laboratories to service a wide range of customers with the need for water, environmental or medical device analysis for microbial and related contamination. Our Bellshill Laboratory has a ISO17025 and ISO13485 accredited quality system and certain test methods are UKAS certified. (see schedule)

Our Dunston Laboratory has been audited against ISO17025 and is awaiting certification.

Our team of microbiologists based both in Scotland and England provide a fully integrated service, comprising technical and consultancy support to our customers across the UK.

Our experienced qualified microbiologists conduct customer site visits and also offer technical support by telephone or email.

Testing conducted is GMP complient and approved by the MHRA in accordance with ISO13485, ISO14644 and ISO14698.

Medical Devices / Pharmaceuticals

Andersen Caledonia specialises in cleanroom environmental monitoring services, and medical device product testing.

Cleanroom Environmental Monitoring:

  • Airborne Particle Concentration Counts

  • Active Air Microbial Sampling

  • Surface Microbial Sampling

  • Passive Air Microbial Sampling

  • Personnel Finger Dab Microbial Sampling

  • Filter Face Velocity Testing/Air Change Rate Calculations

  • Cleanroom Pressure Difference Testing

Medical Device Product Analysis Range:

  • Bio-burden – analysis consists of total microbial, fungal and spore count

  • Endotoxin – analysis is conducted using kinetic turbidimetric method with a sensitivity to 0.01 EU/ml which is complient to USP 85 & USP 161

  • Protein – analysis is conducted using the PRO-Reveal or Coomassie Blue Method

  • Chemical Residual – analysis is conducted using the Total Organic Carbon (TOC) method

  • Gas residual testing (ETO)

Hospitals, Facility Management & Water Companies

Andersen Caledonia offers a wide product range which includes; cleanroom environmental monitoring, instrument/product analysis, water/steam microbial and chemical analysis, and a range of field engineer test kits.

Cleanroom Environmental Monitoring – see Medical Devices/Pharmaceuticals for further information

Intrument/Product Analysis – see Medical Devices/Pharmaceuticals for further information

Hospitals, Facility Management & Water Companies

  • Total Viable Count (TVC) (RO/Dialysis/Tap Water)

  • Legionella

  • E.coli

  • Coliforms

  • Enterococci

  • Environmental Mycobacteria

  • Pseudomonas aeruginosa

  • Endotoxin

  • Total Organic Carbon (TOC)

  • Chemical Analysis (full range of analysis to comply with various standards)

Andersen Caledonia can provide analysis in accordance to various standards including: SHTM2030, HTM01-06, HTM01-01 Part C, HTM01-01 Part D, BS EN 15883, HTM04-01, Water Supply (Water Quality) Regulations and BS ISO 11663.

Hospital Test Kit Services

Endoscope Washer Disinfector Test Kits:

  • Test Soil in various volumes (50, 100 & 250mls) in accordance to BSEN 15883-5 Annexes R & N

  • Water Analysis Kits (Kits include dosed microbial bottles, non dosed chemical bottles and endotoxin test vials)

  • Inoculated Surrogates (Inoculated with a range of different organisms) in accordance to BSEN 15883-4

  • Bio-film test devices (Inoculated with Pseudomonas aeruginosa) in accordance to HTM01-06 Part E/HTM 2030

Drying/Storage Cabinet Kits:

  • Contact Plate Kit for Cabinet Surface Sampling in accordance to BSEN 16442-1

  • Settle Plate Kit for Cabinet Air Sampling in accordance to BSEN 16442-1

  • Sterile Surrogate Test Devices for Channel Microbial Sampling and Storage Time Validation in accordance to BSEN 16442-1/HTM01-06 Part D

UKAS SCHEDULE
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