Regulatory Compliance Update Bulletin: Temperature Monitoring — Q1 2026
Several significant regulatory changes affecting temperature monitoring across food manufacturing, pharmaceutical distribution, and medical device production came into force in the United States at the start of 2026. This bulletin covers the FDA QMSR, FSMA Food Traceability Rule, USDA FSIS Salmonella standards, WHO vaccine cold chain guidelines, and USP Chapter 1079.2 updates.
- Temperature Indicators Staff
- Tags: Cold Chain Food Processing GDP Compliance HACCP ISO 11140-1 Medical Sterilisation Pharmaceutical Regulatory Compliance
ISO 11140-1 Chemical Indicator Classes Explained
Chemical indicators used in medical device sterilisation are classified under ISO 11140-1 into six classes — Class 1 through Class 6 — each with a different function, placement, and level of process assurance. Selecting the correct class for each application is a regulatory and best practice requirement for sterile services departments, CSSD units, theatre sterilisation teams, and any facility that processes reusable medical devices. This guide explains what each class does, when to use it, and how they relate to common sterilisation systems including steam, hydrogen peroxide, ethylene oxide, and low temperature steam-formaldehyde.
- Temperature Indicators Staff
- Tags: CSSD ISO 11140-1 Medical Sterilisation Sterile Services
