CET Group | Clean Rooms
Engineer, Engineering, Geelong, CET Group, Innovation, Compliance INDUSTRIES. CET Group provides value to many industries through our wide range of skills and experience. SERVICES. CET Group can work on specific tasks or run the whole job for you. Check out the services we can offer. PROJECTS. CET Group has worked on varied projects in both scale and product. Click to see our most recent projects. Innovation. Finding innovative solutions to problems is what puts CET Group above the rest. Engineering. Providing precise and calculated results based on experience, evidence and engineering principals. Compliance. Following national, regional and company standards to achieve safe and efficient outcomes.
Engineer, Engineering, Geelong, CET Group, Innovation, Compliance
22394
page,page-id-22394,page-child,parent-pageid-21535,page-template-default,ajax_fade,page_not_loaded,,select-theme-ver-2.3,wpb-js-composer js-comp-ver-4.5.3,vc_responsive
 

Clean Rooms

Planning a Cleanroom?

 

At the planning phase there are a number of concepts to be developed and there are decisions to be made.  CET Group can offer innovative solutions, based on sound experience, to assist in this value-adding phase. Deliverables from this work typically include:

  • User Requirement Specifications;
  • Design concept development documentation;
  • Technical and functional descriptions;
  • Validation and compliance planning documentation;
  • Project plans, estimates and timelines.

 

These packages of work can then form the basis for taking the next steps, such as presentation to financial backers, submission to Regulatory or planning bodies and approaches to major potential equipment suppliers or contractors.

 

At CET Group we believe it is paramount to integrate the clean room solution with the:

  • Process (or functional) needs;
  • GMP / QA needs;
  • Building structure and envelope;
  • Architectural and fit-out details.

 

When specifying a clean room system, CET Group looks at all angles, taking into account such things as:

 

relationshipdiagram
001

Process

  • Key user requirements;
  • Process needs, analysed via flow diagrams, block charts, utilisation schedules – Includes all functions, especially secondary activities such as cleaning;
  • All important functional relationships identified diagrammatically, especially barrier transfers;
  • Size of major equipment items;
  • Process derived service demands;
  • Air flow patterns, positioning of terminal HEPA filters at critical locations;
  • Flows of personnel, materials and equipment into and out of the facility;
  • Optimisation of air change rates and pressure/vacuum regimes;
  • Pressure and vacuum control philosophies including overshoot protection;
  • Piping studies to minimise piping runs in the process areas.

GMP/ QA

  •  Governing regulatory authority (TGA / USFDA);
  • Relevant GMP code(s) / quality standards;
  • Validation master plan (critical parameters, acceptance criteria);
  • Formalised GMP reviews;
  • DQ, IQ, OQ, PQ protocols and validation reports;
  • Manuals and compliance documentation.

Building structure and envelope

  • Acceptable leakage rates for clean room envelopes;
  • Design / specification of all clean room fabric elements consistent with desired leakage rate;
  • Maximum positive and negative pressures to be applied to structure;
  • Design / specification of structure to:
    • Withstand extreme pressure excursions;
    • Avoid sagging / panting of clean room skin under dynamic load;
    • Avoid damage to clean room seals due to excessive movement.
  • Available space in the structural concept to be adequate for services reticulation, especially for large air handling ductwork, and for routine testing and maintenance;
  • Allowances for the loss of room volume due to:
    • Supporting structures;
    • Cavity walls;
    • Return air ducts;
    • Wall thickness to withstand pressure/vacuum.
  • Allowances for the set-downs for weigh platforms, cold rooms, autoclaves, etc;
  • Allowances for large penetrations in the early construction phase.

Architectural and fit-out

  • Clean room skin system options:
    • Sandwich panel;
    • Stud plaster / hardboard, vinyl lined;
    • Proprietary clean room systems;
  • Door, window and pass through details;
  • Penetrations, security and fire rating;
  • Use of glass for visibility, safety, aesthetics;
  • Integration of process, mechanical and electrical services outlets with clean room skin / interface details, such as wall panels, concealed piping, and built in fixtures;
  • BCA compliance;
  • Spatial allowances for wash bays, operations and maintenance.

 

 

Why talk to CET group?

Sometimes the importance of the clean room infrastructure and services is overlooked in the development phase, such as:

  • strength and deflection criteria for the building structure;
  • size of working areas and change locks.

At CET Group we can provide invaluable experience and innovative solutions to integrate all aspects that make-up a clean room

AnimationMediumLogoPSP0808