Dear Pharma Pals,

Cleanroom validation plays a pivotal role in industries where product quality, safety, and regulatory compliance are paramount. It confirms that these environments meet specific standards and consistently function as intended, safeguarding product integrity and consumer well-being. Pradip Bhalerao, a respected figure in the Indian pharmaceutical project industry, writes on Cleanroom Validation in the exclusive in this issue.

For a successful validation, it is of utmost importance to have an all-inclusive and well-thought-of design for the cleanroom. The essence of any successful cleanroom validation lies in adopting Quality by Design principles.

When designing a cleanroom, it’s important to take into account the amount of space its mechanical equipment takes up. In the design stages, keeping flexibility in mind is essential, as this helps with issues of expansion and modification further down the line, as well as with the addition of new equipment and tools as necessary. Read on the requirements to consider when designing a new cleanroom. The article also reminds us that the impact of a failed cleanroom validation on the cost of a project can be significant and multi-faceted as the majority of resources are consumed by the project by the time it reaches the validation stage.

In recent years, formulations based on pellets have been the trend. New technologies make it possible to circumvent property rights for active ingredients and are therefore very popular with pharmaceutical customers. The article by Klaus Möller, Head of Business Development, Glatt Process Technology, discusses the technologies that are the most important.

Harjit Singh Dhaul
Publisher & Editor