WHY USE
It is a requirement that all temperature monitoring devices be calibrated on a periodic basis, typically once per year, with traceability to national standards. The management of the process can become onerous, and failure to effectively manage this process could result in non-compliance and patient risk. Let us do this for you.
Strategnos has strategically partnered with local calibration laboratories to calibrate temperature and humidity recording equipment according to SANAS (South African National Accreditation System), traceable to ILAC (International Laboratory Accreditation Co-Operation).
We can manage the entire process and supply certificates of review indicating all requirements for all equipment have been achieved
NOTE: This service is available only for clients who enter into a Service Level Agreement for other services within the Cold Chain environment.
Calibration of:
- Temperature probes
- Humidity probes
- Loggers
- Ultra-low temperature equipment
- Infrared guns
- Fixed and wireless equipment.
REGULATORY OVERVIEW
SAHPRA
South African Health Products Regulatory Authority
Good Wholesale Practice for Wholesalers – 2016
SAPC
South African Pharmacy Council
Good Pharmacy Practice – 2017
14.4.5. Monitoring equipment should be calibrated once a year.
2.3.5.3. (l) Any recording devices/instruments must be calibrated annually against a certificated standard.