cleanroom technology and gmp

www.ramboll.dk

Rambøll Denmark sets the trend in the Danish market for technical consulting services. We offer full knowledge based solutions within main fields of: Building and construction, transport and traffic, water and environment, energy, oil and gas, telecommunication, industry and waste.

Rambøll Denmark is part of The Rambøll Group, the lead-ing Nordic consulting group with more than 4000 employ-ees. The Group also includes the Danish companies Rambøll Informatik and Rambøll Man-agement.

Knowledge taking people further

Cleanroom Technology and GMP---

Selected References

H. Lundbeck A/S Denmark

Core competencesMany years of designing Cleanrooms in close collabora-tion with our customers, has specialized us in:- HVAC for Controlled Environ-

ments; Cleanrooms and Contamination Control

- UDF-modules- Clean steam, clean gasses,

compressed air etc.- Water (PW, WFI etc.)- Facility Monitoring System- Cleanroom Performance

Testing- Qualification / Validation

We actively work with knowl-edge management from one project to another. That benefits the clients as well as quality and costs. Our team takes part in all phases of a project from the first idea to the final Cleanroom testing and validation.

HVAC for CleanroomsThe HVAC-system is essential when it comes to designing Cleanrooms. Rambølls experts

have been consulting engi-neers for the pharmaceutical industry for many years, which at the same time have strength-ened our specific and interdis-ciplinary know-how. Our experts are innovative and members of several orga-nizations within Cleanroom Technology, where they have made their mark for instance by publishing a “Filter guide” regarding filters for HVAC-sys-tems. In for instance aseptic production UDF-modules (Uni Directional Flow) are required for filling areas etc. Rambøll has been consulted many times about design of UDF-modules.

In some projects we have designed and implemented different custom-made solution for shielding of personnel for protection, buoyancy caused by heat emission, and uniform velocity of air etc. Sometimes we have successfully used untraditional methods as CFD-models and visualization by smoke/gases.

Clean water, steam, gases etc.In order to obtain uniformity for the products it is absolutely necessary to have control of the quality of the different supplies (water, steam, gases, com-pressed air etc.) which are used in the controlled environments. When planning and designing such installations it is very im-portant that the requirements for the quality of the water etc. are specified in advance.

Rambøll can in close collabo-ration with the Client help to define requirements for the Cleanroom facilities and con-trolled environments; combin-ing the Clients own experi-ences with Rambølls know-how to ensure the right solution in the end.

Validation and Cleanroom TestingIt is Rambølls experience that the final validation should be visual from day one of a proj-ect. By an early risk assessment

it should be determined which supplies and facilities are to be validated. This risk assessment must be documented in order to demonstrate control to the regulatory agency. Rambøll is very experienced carrying through test and validation for major pharmaceutical com-panies, according to both na-tional, European and American (FDA) standards.

The trend at the moment is to establish continuous Facility Monitoring Systems (FMS) for particulate matters, tempera-ture, differential pressure etc. Rambøll has taken part in set-ting requirements, designing and validating such systems. When it comes to Cleanroom Performance Testing as part of the validation, Rambøll is examined by NEBB, U.S.A. to perform the tests.

Rambøll employeesOur team of experts has extensive technical and special knowledge, as well as strong

Working with Cleanroom Technology and GMP demands preci-sion and know-how. Therefore Rambøll has put together a team, which during the past 20 years has specialized in installa-tions for Cleanrooms and Controlled Environments.

Statens Serum InstitutCopenhagen

Stem Cell Research,Aalborg Universitet

Centralapoteket Herlev

Knowledge Forum for Cleanroom Technology and GMP

personal characters, which is part of making Rambøll a well-acting Nordic Consulting Company. Our goal is that our employees spend more than 30 hours annually on supplemen-tary education in both Europe and the U.S.A. We believe that the combination of ongoing supplementary education and project work provides the best possible foundation for ongoing development of core competences and excellent consultancy to the benefit of our clients.

Procesforløb

Process concept

Product safty specification

Risk assessment Enhanced

design review

Supplier phase

Preliminary design

Design

Construction

CommissioningFAT & SAT

Preliminary production

Preliminary risk assessment and

specification review

Safe SOP development

Commercial operation