SERVICES

What we can do for you

B&A distinguishes itself as a company that focuses on certifyingsystems and devices for air controlin sensitive environments, such as clean rooms and controlled environments.

Our activity focuses on sectors characterized by strict quality regulations for their environments, with particular attention to the hospital, pharmaceutical and advanced therapy sectors.
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HVAC qualifications

A properly functioning HVAC or air conditioning system is essential to ensure the necessary cleanliness to everything around the product. The HVAC system must be adapted to provide the cleaning classification required by your process, be it production, conditioning or development.

For the proper functioning of your HVAC system, B&A qualifies the system with the following steps:

Qualification of DQ design:

compliance with design requirements (agreement between technical specifications and user requirements).

Qualification of IQ installation:

verification of compliance of the system architecture and its components with requirements.

Qualification of OQ operation:

Verify that the installation works as required. In this phase, various parameter measurements will be performed, such as particle count, class recovery, filter integrity, air renewal in the environment.

Qualification of PQ operation:

verification over time of the maintenance of the required conditions for the premises and verification of parameters such as particle count or recovery of classes in clean room working conditions.

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Tests performed in accordance with ISO 14644

We guarantee compliance with ISO 14644 and current GMP standards. Test list:

• Smoke test
• Cross flow verification
• Leak test in installed absolute filters
• Airflow (speed, flow, spare parts now)
• Difference in pressure
• Temperature and humidity
• Pressure drop of filters
• Index of air cleaning
• Environmental microbiological quality
• Calibrations Probes

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Thermal Mapping

Any thermal equipment involved in your critical process is susceptible to qualification and must be controlled. They range from storage equipment, such as cryocontentors, freezers, cold rooms, incubators, stoves or stability chambers to equipment used for sterilization, such as autoclaves.

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Qualification Laminar Flow Hoods and Insulators

We check your hoods on a biannual basis. In this intervention we carry out a series of checks to assess its suitability and operation for the process that takes place there.
Tests under ENAC accreditation / ACCREDIA and staff always up to date.