Some of the most important sectors in the world heavily rely on validation. The procedure guarantees that the machinery utilized in each industry—from health sciences to aerospace to food and beverage—performs within specific constraints.
What is Thermal Validation?
Thermal validation ensures that temperature-controlled equipment, such as ovens, incubators, and chambers, operates according to the manufacturer’s specifications and is maintained within a predetermined range. It is a critical process used by laboratories and production plants to ensure that products are kept within the correct temperature range to ensure the safety and quality of the end product.
What to consider before performing a Thermal Validation?
Before performing a thermal validation, it is important to be aware of the following five things:
1. Understand the standard
Different standards control thermal validation. There isn’t a one-size-fits-all solution for all businesses or equipment; therefore, adjusting the protocol is necessary to the right standard. For instance, a warehouse could follow ASTM guidelines, while an incubator might be certified under World Health Organization (WHO) requirements.
2. Understand the equipment
Only some of the equipment undergoing validation is equal, much like the standards. The sort of validation to be carried out depends on the size of the stability chamber, which can range from the size of a bench unit to that of a small room. The validation processes are determined by variables like the size of a piece of equipment, which is just as precise as where the probes are placed.
3. Use the proper equipment
Several instruments, including thermocouples, RTDs, and data recorders that can be connected or wireless, can be used for thermal validation. For instance, mapping a warehouse would need more than 100 data loggers, necessitating a wireless strategy. Since wireless data loggers are ineffective at temperatures below -80°C, it may be necessary to use cable thermocouples when verifying in a very cold environment. Understanding the constraints of the various systems and implementing the best ones is crucial, with hybrid strategies occasionally being considered.
4. Observe the proper protocol
When it comes to appropriate validation, the devil is in the details; thus, the protocols must adhere to the standards. This calls for a solid grasp of good manufacturing practices (GMP), which entails thoroughly documenting the required processes.
5. Get your technicians the right training
It is also very critical that technical personnel in all validation processes are adequately instructed on the standards they are using – particularly on how to apply, evaluate and report on those standards.
Final words
In conclusion, performing thermal validation is an important process in any product development. After considering the five factors mentioned here, it is evident that the process is complex and should be done carefully. When done correctly, the benefits of performing a thermal validation are clear and can positively impact overall product performance. With careful consideration and planning, any organization can successfully conduct a thermal validation that meets its needs while providing the best possible results.
Join us on the 22nd of February for valuable insights and real-world examples from our guest speakers so that you can ensure the success of your thermal validation effort:
With a dedication to serving the pharmaceutical industry, Qualistery specializes in hosting informational webinars that support both professionals within the pharma sector and service providers. Our commitment lies in empowering businesses to maximize their impact through engaging virtual events and strategic webinar solutions. Additionally, Qualistery supports life science companies through private GxP training and compliance services.
