Cleanroom experts
Technical Services
Technical services are essential to ensure the proper operation and maintenance of clean rooms and classified spaces.
In addition, these services ensure the qualification and certification of the installations according to the applicable regulations, guaranteeing maximum performance and efficiency, minimizing downtime and maximizing the useful life of the implemented systems.
The fastest and most economical solution
Pre-Validation of Clean Rooms
To ensure compliance with GMP, ISO-EN 14644 and FDA regulations, applicable in the various cleanrooms and classified spaces, it is necessary to contract a validation service from 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.
This is why we have created our exclusive pre-validation service, which consists of a preliminary review of the installations and the preparation of a report on their condition, 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.
This way, with no surprises, no loss of time, no duplication of costs, you can complete your validation with a single supplier and all the guarantees.
1. Inspection
We analyze the key points of the installation and collect the essential information.
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 with total guarantee of success.
We guarantee regulatory compliance
Validation and certification
At Iguña, we perform qualification and validation services in the certification of cleanroom architecture and facilities, ensuring compliance with the objective standards of the GMP, ISO-EN 14644 and FDA regulations. Our specialized technical team is in charge of preparing a Validation Plan that defines the scope and methodology to be followed, ranging from Sanitary Architecture to HVAC, Control, Electricity and Critical Fluids Installations.
For the validation of HVAC installations and the attribution of an ISO classification to classified areas, we perform tests including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Process Qualification (PQ). These tests ensure that the cleanroom design, installation, operation and process comply with legal safety requirements, technical specifications and normal and boundary operating conditions.
Whether for one-off projects or comprehensive (360º) turnkey projects, at Iguña we are committed to guaranteeing excellence at every stage of the process to meet all your cleanroom validation and certification needs.
1. Design Qualification (DQ)
The DQ qualification document will determine if the design of the equipment conforms to legal safety standards, and compliance with the concordance between user requirements around the design and the technical specifications finally defined.
2. Installation Qualification (IQ)
The IQ qualification document will show that the installation has been carried out in accordance with user requirements, and will present the following sections:
- Verification that the facilities, systems and equipment are in accordance with the engineering drawings and specifications.
- Characterization of surfaces, construction materials and finishes of the room.
- Calibration requirements.
- Checking the air conditioners, ducts, and air supply and return elements.
- Preparation of the final report of the Installation Qualification
3. Operational Qualification (OQ)
The OQ qualification document will be made with production stopped and will present the results of:
- Leak test in the room filtration and air conditioning system.
- Test flow rates and hourly movement rates
- Pressure difference test
- Temperature test
- Relative humidity test
- Noise level test
- Airborne particulate count test
4. Process Qualification (PQ)
The PQ qualification document will determine the environmental quality of the space, measuring the level of particles under normal operating conditions and, with limit operating conditions. Presenting the results in situations of maximum and minimum, of:
- Leak test in the room filtration and air conditioning system.
- Test flow rates and hourly movement rates
- Pressure difference test
- Temperature test
- Relative humidity test
- Noise level test
- Airborne particulate count test
Ensuring service life and regulatory compliance
Maintenance
At Iguña, we perform preventive and corrective maintenance to extend the useful life of the clean rooms and guarantee compliance with the required GMP, ISO and FDA standards.
We offer this service both as an after-sales service for rooms executed by us and to improve classified areas installed by third parties.
Preventive Maintenance:
We agree with the property the frequency and elements to be checked in Architecture, Air Conditioning, Electricity, Lighting, Regulation and Control or Critical Fluids, as well as the consumables to be replaced. We reflect in a Maintenance Dossier the data to be reviewed and, at the end of each intervention, we deliver a report on the state of the installations and recommendations for detected anomalies. The thoroughness of our documentation allows us to present it in internal and external audits.
Corrective Maintenance:
We understand the importance of avoiding downtime in a Clean Room. Therefore, in the event of a breakdown, we are committed to respond to the request for intervention within 24 hours. In this way, we ensure business continuity and compliance with the required regulations.
SAT Immediate Response
Technical Assistance
Iguña offers an efficient Customer Service Department ready to answer your questions or needs related to Clean Rooms.
Our team strives to resolve your concerns via telephone, online or, if necessary, in person.
To contact us, you can use our contact form, send an email to sat@igunapharma.com or call us at +34 93 784 28 25.
We are at your disposal to provide you with the attention and support you require.
