Validation Services

Pharma Technologies is engaged in offering prompt Cleanroom Validation Services that are carried our high proficient technical staff.

We make the complete layout and discus it with client so that we can receive the approval of the clients followed by various tests and bringing on accurate instruments. Testing normally include airborne particle counter, Filter integrity testing (DOP), air supply and extract volumes and air changes rate calculation, differential pressure, temperature and relative humidity measurement.

Herein, anything found unusual will be reported immediately to the clients and then accurate steps will be taken to certify the error. We report in proper format that too in accordance with industrial standards and then we inform customer about non-compliance with calibration certificate, printed reports, traceability certificate & SOP,etc.

The performance of your equipment or facility is critical to the protection of the product, and in certain applications the end user. It is therefore vital your equipment is maintained in a fully functional and serviceable condition.

Our in-house capability can offer to validate:

• Cleanrooms
• Softwall cleanrooms and mobile enclosures
• Containment suites
• Laminar flow cabinets
• Biological safety cabinets
• Isolators

All of the above will be validated to the appropriate standards.
Using equipment with calibration trace ability Pharma Technologies can perform:

• HEPA Filter installation leak tests to PD6609
• Airborne particle counts to ISO 14644 / BS5295 / cGMP / Fed 209e
• Room pressure measurements
• Airflow balances
• Recovery performance
• Noise and lighting levels
• Air flow visualisation
• Air flow and airchange rates
• KI containment testing to EN12469
• Laminarity measurements

All results will be issued together with a professionally written report.
Pharma Technologies can also provide the following protocols to obtain MCA /FDA approvals.

• Design Qualification Protocol
• Installation Qualification Protocol
• Operation Qualification Protocol

Commissioning

As required by the relevant Standard BS EN ISO 14644 covering clean air environments, the performance of all clean air devices should be monitored on a regular six or twelve monthly basis. Pharma Technologies experienced Service Engineers check and monitor all significant indicators in the users' presence providing a full Service Report and Certificate of Conformity after each visit.
Pharma Technologies Service Engineers are all highly skilled in repairing and maintaining a wide range of environmental control systems not just those designed and installed by our own project teams. Our services include:

• Regular inspection visits with a breakdown callout service
• Maintenance of all types of clean rooms
• Maintenance of clean air and containment equipment
• Full in house validation capabilities
• HVAC Testing
• Maintain and repair the structure or assembly of your system
• Balance airflows within the facility to maintain the correct air change rate and pressure differentials

Priority Call out Service

Where on site attendance is requested other than coinciding with the visits scheduled under a Service Agreement, Pharma Technologies offers a priority call out service inclusive of all mileage and travel charged at either daily or half daily basis.

Providing Total Engineering Support

All our service engineers are highly skilled and multi-disciplined and we are equipped to deal with the majority of system breakdowns. In-House operatives are also available for unexpected emergencies.
If necessary a Service Engineer can speak to our design and project engineering staff for additional advice and information. For any project designed and installed by Pharma Technologies, the original plant drawings can be located on computer, which will help to find and rectify faults quickly and efficiently.

Efficient Operational Control

The Service Department uses a fully computerized service management system, which allows progress on all maintenance work to be monitored, ensuring better response times to Client problems and more efficient management of the whole service operation.
Our Service and Maintenance Department would be pleased to provide further details and quotations upon request.
Pharma Technologies offer service and preventative maintenance programmes to ensure reliability of your equipment or facility.

Pharma Technology can provide:

• Service and maintain clean air systems to the appropriate standards and supply supporting documentation
• Maintain and repair the structure or assembly of your system
• Balance airflows within the facility to maintain the correct air change rates and pressure differentials
• Offer an emergency call out service
• HVAC testing

In addition to offering planned preventative maintenance contracts twice annually for our own products and services we can also undertake the commissioning of new or refurbished installations.
Where on site attendance is requested other than coinciding with the visits scheduled under a Service Agreement, Pharma Technologies offers a priority call out service inclusive of all mileage and travel charged at either daily or half daily basis.

Airborne particle counts, air velocity readings, smoke visualization demonstrations and filter leak testing is carried out using modern test and recording equipment, which is calibrated on a regular basis in accordance with our ISO Certified quality assurance procedures.

Our Service and Maintenance Department would be pleased to provide further details and quotations upon request.
Clean Air Workstations tested and validated to BS EN ISO 14644.
Horizontal, vertical and reverse.
Softwall Cleanrooms and Clean Air Enclosures.
Cleanroom testing and validation, particle monitoring.