How Does the Future of Medicine Look Like? Luis Charles
Validation – Pharma vs Medical Devices José Sergio Ávila
The covered topics:
Click here to see some of the questions that Yan asked Sergio.
EtO is a mutagenic and carcinogenic gas. Manufacturers usually used for sterilization of materials that cannot withstand high temperatures. The gas destroys microorganisms by targeting their cellulars proteins and DNA.
The EtO Sterilization cycle has three stages:
During this phase, operators prepare the sterilization chamber’s environment for the required conditions. It includes parameters such as temperature, pressure, and humidity. Because EtO works only in a humid climate, the chamber is filled with steam. Then, the chamber is hit to the required temperature, which is somewhere between 22-55°C.
During this face, EtO enters the chamber. Higher gas quantity gas means quicker sterilization. However, it is crucial to keep the gas quantity at a minimum minium, as plastic materials tend to absorb the vapor, according to their properties. Therefore, it is essential to achieving the right balance.
This phase is significant, as it removes that gas from the chamber and ensures that the sterilized materials release the absorbed gas. This phase is long and usually lasts 48 hours.
Before using the methods, each chamber must be qualified and validated.
When validating the sterilization process, it is essential to take into account the density of the product and the packaging. Those parameters have a significant influence on the way the EtO gas or the gamma radiation interacts with the sterilized product.
According to Sergio, one of the most critical processes in parenteral is the water for injection. It has a significant impact on the purity of the product and may pose a considerable risk for patients. Manufacturers must validate the systems according to the applicable pharmacopeia.
The most critical parameters in pure water systems are:
The validation of water systems has 3 phases. The first two phases last at least two weeks. The third phase lasts one year. After completing the first phase successfully, the manufacturer is allowed to use the water for production but must monitor closely.
The biggest mistake that people do during the validation of purified water systems is contaminating it during sampling. So always be careful when you open the sampling valves! Otherwise, you have to start all over again!
Essential things to keep in mind with water for injection systems:
When you validate medical devices, you have other factors to consider than in the pharmaceutical validation. Manufacturers of medical devices use a lot of plastic, and there is a lot of welding, molding, and injection involved. Also, there is the crucial assembly step. All the equipment has to be qualified, and the steps validated. The main factors in medical device manufacturing are the operators who perform the assembly. These employees train in assembly and welding operations and clean room etiquette.
Also, to ensure the safety of the product, extensive statistical analysis needs to be performed. For example, manufacturers need to make sure that the battery in a heart pacer won’t fail. To ensure that, they use methods such as Six Siga, Five S, and sampling plans. The more critical the device, the higher the confidence level it requires (AQL = Acceptance Quality Limit).
Sergio believes that critical pharmaceutical systems are more challenging to validate than medical device processes. The reason for that is that medical devices have a sterilization step in the end, which reduces risks to patients.
Sergio suggests spending at least one hour per week reading industry magazines articles.
Here are some of Sergio’s recommendations: