PRE-VALIDATION OF Clean Rooms
The most efficient and economical solution to certify your clean rooms and classified areas
Clean Rooms pre-validation service
The fastest, most efficient and economical solution to certify clean rooms and classified areas
To guarantee compliance with the objective standards of the GMP, ISO-EN 14644 and FDA regulations, applicable in different clean rooms and industries, it is necessary to contract a validation service to a specialized company.
On many occasions, this validation is denied due to the breach of an obligation or the error in certain parameters. In these cases, the client is also obliged to pay for the validation service, to make the necessary adjustments and to contract, again, a validation process.
That is why we have created our pre-validation service, which consists of a preliminary review of the facilities and the preparation of a report on their status, plus a list of the adjustments that should be made, if necessary.
With this service, which has a cost significantly lower than that of a validation, at Iguña we reduce the overall costs of the process by simplifying and speeding up the analysis – adjustments – validation cycle.
In this way and without surprises, or wasted time, or duplication of costs, the customer can complete their validation with a single provider and all the guarantees.
If you need a validation service, count on Iguña Pharma! We are specialists in the integral development of clean rooms with more than 20 years of experience.
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Process
6 steps to guarantee a correct validation and certification of your clean room
1. Inspection
We analyze the key points of the installation and take the necessary measures with the greatest precision.
2. Report
We write a technical report that determines which aspects do not comply with the standard.
3. Modifications
We make a list of corrective actions to comply with the standard.
4. Budget
We make a project proposal to ensure that the installation complies with the standard.
5. Settings
We take care of all the necessary adjustments and changes, adjusting to the deadlines and budget.
6. Validation
We carry out the validation and certification of the installation.
Benefits
The 5 main virtues of our pre-validation service
- Cost reduction in the global certification process
- Simplification and streamlining of the analysis process - adjustments - validation
- No surprises
- No duplication of costs
- With a single supplier for the entire process
