P1000292ISO 7 Hard wall Clean Room

Client: Cenobiologics

Scope of Project: We were commissioned to provide a Pharmaceutical Clean Room for Sterile product packaging and Aseptic filling. Four Rooms were needed in total – Scrub Room, Changing Room, Freeze Dry Sterile Packing Room and an Aseptic Filling Room.This project included a full design and build service, which we took care of from planning to handover.

Location: Bedfordshire

Job Specifics: I/Q O/Q P/Q Validation and Protocol –  for the client to attain their accreditation and production licenses from the HTA (Human Tissue Authority)

The Clean room and associated equipment was required to meet the design and construction elements of the relevant HEVAC regulatory standards, guidelines and industry best practices to EU cGMP Class A and Class B

ISO 7 & 5 14644 -1 standards.

All Materials were to be Resilient to Chemicals used for sanitization and clean-down.

Challenges: There were several challenges which Maplin had to overcome,  namely to integrate the facility into an existing old building which was previously used by the U.S. Eighth Air Force as part of a World War II Aircraft Communications Complex. Although the building was made available to us totally stripped out, there were various building constraints levied by the Landlords.

The required operating conditions were:        20⁰C ± 2⁰k      40% RH ± 10%

Four rooms were requested for this facility with the following classification and cascading pressure gradients:-

Room Reference Description Dimensions L x D x H   mm Class /Pressure
Scrub Room 1st stage ingressFinal stage egress 2800 x 1500 x 2300 ISO 7 / 15Pa
Changing Room 2nd  stage ingress 2100 x 1500 x 2300 ISO 7 / 30Pa
Freeze Dry sterile Packaging 3rd   stage ingress: 2540 x1500 x 2300 Class A / ISO 5 / 45Pa
Aseptic Filling Final stage ingress1st stage egress 6340 x 2800 x 2300 Class B / ISO 7 / 30Pa

The Greenworks Controlled Environments Touch: Providing a great service for our clients involves more than just getting the job done – provisional site meetings were attended by all parties mainly to produce a workable platform on which to base the clients URS, also to discuss conformity to all building and installation requirements.

We have over 40 years’ experience designing, building and installing be-spoke air conditioning solutions for all sorts of process manufacturing requirements. Many of which have been in other countries in all parts of the world and continue to be supported by our service department, bespoke manufacturing facilities and BMS/Control Systems logging and bureaux desk.

Principal equipment installed: The HEVAC requirements were provided by an MCE Maplin Controlled Environments) bespoke Air Handling Unit which included EU7 Pre-filters, thyristor controlled heater battery, inverter controlled fan, steam humidifier and a central control Panel.

A peripheral insulated duct work system was configured to suit both the air distribution requirements and the buildings low ceiling constraints.

An externally sited Condensing unit operating on R410A refrigerant provided the staged cooling requirement for maintaining the temperature.

A TREND based energy management control system was designed and configured by MCE for the regulation and control of all the equipment.

MCE are an approved TREND system integrator and were able to provide a further Control monitoring system with Web Page Enabled Data Logging for the clients in house validation requirements.

The Class A – ISO 5 14644-1 Sterile Packaging room incorporated external Freeze drying equipment with an integrated glass transfer door and a further polycarbonate spring assisted door for passage to the aseptic filling room.

Three H15 ULPA ceiling terminals with perforated diffusers provided 360 Air changes/ hour with a unidirectional air flow.

The Class B ISO 5 14644-1 Aseptic Filling room incorporated two laminar work stations and two st/st interlocked transfer hatches.

Three H14 HEPA ceiling terminals with four way discharge diffusers provided 100 Air changes/ hour with a non-unidirectional turbulent air flow.

Strategically placed return air grilles and Pressure relief dampers provided the return air and pressure relief paths.

A series of electrically interlocked doors with monitored sequence were provided for passage through the facility.

  • The Lighting was designed to provide 400 Lux to all areas.
  • A filtered fresh Air heat recovery system was installed to suit the number of personnel working in and around the facility.
  • Anti-static seamless vinyl welded, coved flooring was installed to suit the point of use requirements.

The Result: The turnkey facility was handed over to the client after undergoing successful validation by a third party organization. All aspects of the critical values and sequences were validated in accordance with the  I/Q – O/Q – P/Q stipulations.

The facility was completed in a seven week build program, on target and on budget, utilizing MCE’s in-house design, installation and project management team.

For further information please contact David Golding

Business Manager – Greenworks Controlled Environments Ltd.  T/A Maplin Controlled Environments.

t: +44 (0)1245 324188  m: +44 (0)7909 964155  e-mail: nbarton@gceuk.co.uk