Cleanroom Validation, Validation Documentation

Validation

Documentation

PARSAN Engineers and Consultants, a group of expert technological and different kinds of solution providers offers quality services to multiple industries throughout the year. We have dedicated team, full of proactive members who plan, and implement the strategies they take from time to time in their client business as per the requirement. One such service is validation and documentation of different infrastructure that we provide to different industry operators. Cleanroom Validation is another specialization that we offer to different clients as per their requirement in a reasonable price range. We have certified experts who work on these projects separately and complete the validation process and also documents the data gathered.

What is this all about?

Cleanroom is mostly required in Pharmaceutical, medical, or scientific practical explorations, and we provide cleanroom of different qualities to the client companies. Our team has experience of serving this industry as well for long time now. But now industries require validation of these cleanroom as per regulatory requirements to ensure these rooms are properly structured and all of the components are set with adequate facilities.

In order to validate a cleanroom environment it is necessary to demonstrate that:

  1. air supplied to the cleanroom is of sufficient quantity to dilute or remove contamination generated within the cleanroom,
  2. air supplied to the cleanroom is of a quality that will not add to the contamination levels in the cleanroom,
  3. air moves in the direction from clean to less clean areas,
  4. air movement within the cleanroom shows that there are no areas with the room with high concentrations of contamination, and
  5. manufacturing processes can be done in an environment that meets its microbial contamination levels.

The above situation can only be achieved through proper validation of the system.

PARSAN performs quality Cleanroom Validation as we perform the following for this work-

  • We start our job from validating the equipment. We go through all the equipment and check their condition and assess whether they are capable of performing the supposed works.
  • Cleanroom uses utilities like HVAC, compressed air, water, and more which our expert teams validate.
  • Laboratories using cleanroom also include some instruments, which we validate individually to assess their effectiveness.
  • Validation of the process of work is also important for assessing the effectivity of the cleanrooms. So, we perform this task separately for fulfilment of the project we have got.
  • Assessing the potentiality of risks associated with the cleanroom and its activity is what our validation team performs for the client companies.

Validation Documentation 

Validation is the documented process of demonstrating that a system or process meets a defined set of requirements. There are a common set of validation documents used to provide this evidence. We understand this requirement and so have come up with the Validation Documentation service to perform the documentation of the validation process. This process requires the following activities-

  • As validation assures that the cleanroom is properly designed to meet the needs of the clients, documentation of the process is highly required. We work on that process through different documentations like SMF, VMP, etc.
  • Our expert team also perform validation of qualifications associated with the cleanroom functioning.
  • Changing control, and deviation is also very important a factor in assessing the documentation of the validation process. We consider these facts and work on these factors separately.
  • We work on risk assessment as well. Any structure is prone to some risks, and we work on the possibilities to mention them in reporting the documentation of the validation.

Any client company can rely on PARSAN Engineers and Consultants, as we not only provide you quality solution to meet your requirements but also assure you of complete services for a seamless experience.