VALIDATION AND QUALIFICATION

Sure Laboratories prides itself in helping its clients out with microbiological validation and qualification studies. The Sure Laboratories portfolio comprises a variety of qualification and validation studies such as:

Method validation according to harmonize Pharmacopoeial methods

• Suitability testing according to European Pharmacopoeia 2.6.1 (Sterility)
  
  
• Suitability testing according to European Pharmacopoeia 2.6.12 (Total Aerobic Microbial Count)
  
  
• Suitability testing according to European Pharmacopoeia 2.6.13 (Specified Organisms)
  
  
• Suitability testing according to European Pharmacopoeia 2.6.14 (Bacterial Endotoxin Test)

Challenge tests and Antimicrobial Efficacy Testing

• Antimicrobial Efficacy Testing according to European Pharmacopoeia 5.1.3
  
  
• Antimicrobial Effectiveness Testing according to United States Pharmacopoeia <51>
  
  
• Antimicrobial preservative testing for assessing discard date contact lens care products according to ISO 14730
  
  
• Antimicrobial effectiveness testing of lens care product regiment tests accrediting to ISO 14729 Evaluation of the antimicrobial protection of a cosmetic product according to ISO 11930.

Medical Devices

• Validation sterility test according to ISO 11737-1
  
  
• Validation bio-burden recovery factor according to ISO 11737-2
  
  
• Validation Bacterial Endotoxin Test according to United States Pharmacopoeia <161>
  
  
• Validation of sterilization process according to ISO 11137-2 VDmax²⁵
  
  
• Validation of sterilization process according to ISO 11137-2 VDmax¹⁵
  
  
• Validation of sterilization process according to ISO 11137-2 Method 1
  
  
• Validation of sterilization process according to ISO 11137-2 Method 2

Clean rooms and associated processes

• Microbiological clean room qualification based on EU-GMP and ISO guidance
  
  
• Aseptic filling validation (incubation, reading and performance testing of media fills) according to ISO 13408

Disinfectants and antiseptics (according to European Guidelines)

• Phase 1 testing: Basic bactericidal activity tests according to EN 1040
  
  
• Phase 1 testing: Basic fungicidal activity tests according to EN 1275
  
  
  • Phase 2 / Step 1 testing: Suspension tests with or without organic soil
  • Phase 2 / Step 2 testing: Surface tests without mechanical action (EN 13795)
  • Phase 2 / Step 2 testing: Surface tests without mechanical action (EN 16615)
  • Customized disinfection testing for proving disinfection efficiency of medical devices

  
  Sure Laboratories is member of Technical Committee 216 Disinfectants and antiseptics. TC 216 represents the Netherlands at the CEN commission and advises CEN on European Standards related to microbiological tests.

Contact us for more information

Nikinc Dental