In the individual application descriptions shown below, important information regarding Processes, Challenges, Guidelines and Methods can be found.
Autoclaves in the pharmaceutical and medical industries must comply with established standards and norms (EN 285 and ISO 17665) to ensure that their process continues to provide safe and sterile results.
In order to do so, autoclaves require periodic qualification and validation to prove that they can sterilize within their qualified parameters.
Laboratories in healthcare sectors must be closely monitored in accordance with regulatory procedures, in order to prevent damage to equipment and vital resources.
Critical parameters include temperature, humidity, pressure, and CO2 levels.
Ethylene Oxide Sterilization is a low-temperature process used in the pharmaceutical and medical industries to reduce the levels of infectious agents. This process is preferred for products that cannot withstand the heat of typical autoclave sterilization. Critical parameters include temperature, humidity and pressure levels.
Environmental Test Chamber
Environmental test chambers are suitable for numerous applications: product shelf life, stability and package testing, light exposure and temperature evaluation studies, electronic component burn-in, plant growth, and many more.
They feature precise control of parameters such as temperature and relative humidity.
Hydrogen Peroxide Sterilization is a low-pressure, low-temperature, nontoxic process used in the pharmaceutical and medical industries to reduce the levels of infectious agents. This process is preferred for products that either cannot withstand the heat of typical autoclave sterilization or that have diffusion-restricted spaces such as low lumen medical devices.
Critical parameters include pressure/vacuum, delivered RF energy, H2O2 concentration and temperature. Humidity may also be measured.
Ovens are insulated boxes with adjustable heaters required to achieve high temperatures in the pharmaceutical and medical industries. More advanced ovens may also include the ability to lower the temperature below ambient (via refrigeration), and/or the ability to control vacuum, which also require pressure to be monitored and controlled alongside temperature.
Stability Chambers in the pharmaceutical and medical industries rely heavily on validating critical temperature and humidity parameters in order to accurately measure the effect of these variables on individual drug products. This can help establish vital product degradation information.
Warehouse environments in the pharmaceutical, medical, and food industries may be subject to regulatory compliance, requiring validation and monitoring.
Temperature and humidity are the most common critical parameters, which cannot exceed certain limit values and need to be accurately documented.
CTU's and TCU's
CTU’s and TCU’s are used to avoid further biological activity such as decay in food and medical products. The critical parameter during storage is temperature, but often humidity is also monitored for dry conditions.
Washer/disinfectors are used in both medical and pharmaceutical applications to either prepare goods for future autoclaving (for example surgery instruments to remove residues such as blood and protein) or to disinfect (semi sterilize) goods for later use.