Sterilization is a process whereby manufacturer of Pharmaceuticals ensures that the drugs produced by him is safe for human consumption. This process is governed by strict standards laid down by Food and Drug Administrator (FDA), Good Automated Manufacturing Processes (GAMP), International Society for Pharmaceutical Engineers (ISPE). There are specific predicate rules of FDA for pharmaceutical manufacturers like 21CFR Part 210 and Part 211. For the electronic records, also there is a standard 21CFR Part 11 to be followed and ensured. The key focus of 21CFR Part 11 is on data security, non-tampering of data, identification of the person who carried out what activity and what were the data at that instance of time.
Sterilization is generally performed using moist heat sterilizer. There are other ways of sterilization also like Dry Heat Sterilization, Ethylene oxide or Radiation. All the sterilizers are equipped with some PLC or control systems. They also monitor various parameters like temperature and pressure etc. The stringent verification and validation requirement for sterilization along with the requirements laid down by FDA and GAMP, requires that the process be monitored and recorded independently of control system to ensure 21CFR Part 11 and GAMP compliance. The data along with user activity are stored in binary format to make it temper proof.
G-Tek’s SmartScreen series of Paperless recorder are very useful in ensuring and meeting 21CFR Part 11 and GAMP requirement. It helps to monitor the key parameters independent of control system. Parameters like temperature and pressure are recorded against time. The data can be stored in internal memory for future retrieval. Since all these recorders are having Ethernet Port, when used along with gtekNetTM software, can store the data in centralized server for future retrieval and analysis. Reports like Lethality (F0/Fh), Statistical analysis like Mean, Maximum and Minimum, hold time, MKT etc. are available as a built-in feature. User activity along with data and time is recorded in Audit trail and is available in human readable format for evaluation.
These recorders are also widely used in Milk and Dairy, Food processing, Tyre curing, Freeze Drying, Environmental monitoring, Fermentation process, Flow and Heat treatment and various other process industries.