the a cleanroom company company ltd - stodec company ltd ... precision engineering, pharmaceutical...

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www.stodec.co.ukwww.thecleanroomcompany.com

The CleanroomCompany Ltd

DESIGN & INSTALLATIONOF COST EFFECTIVECLEAN & CONTROLLEDENVIRONMENT AREAS

DESIGNED & INSTALLED TO FIT YOUR PREMESIS & YOUR PROCESSES

• Clean Rooms• CMM Rooms• Modular Enclosures• Softwall Areas• Humidity &

Temperature Control • Laboratory

Furniture& Fit Out

A

Company

A

Company

32987_Stodec_Cleanroom_Brochure_A5_v5_DESIGN.indd 1 29/08/2017 12:44

2 The Cleanroom Company

Welcome

We have been designing, installing and fitting out workplace, production, warehouse and office areas throughout the UK and overseas for more than 35 years. (See www.stodec.com).

Work on cleanroom projects started over 25 years ago for customers who were developing computer assemble and repair areas which required low particle contamination and controlled humidity.

Since then, facilities both small and large have been completed, producing clean and controlled environment areas for clients in aerospace, precision engineering, pharmaceutical research and production, medical device manufacture, electronics, food production, stem cell and cryogenic processes, optical products, coating and finishing processes and many more.

Our customers have included Glaxo, Rolls Royce Aerospace, Roche, Caterpillar, Proctor & Gamble, Perkins, GKN Aerospace, Watson Marlow, Biovault, Thales, Dermal Laboratories, DDD Ltd and many others.

PART OF THE STODEC GROUP DESIGN & INSTALLATION ENGINEERS

About Us - The Cleanroom Company Ltd

01727 840 594 01727 843 368


[email protected] www.thecleanroomcompany.com

ContentsContents

ServicesSome projects only require our cleanroom panel enclosures, others need plant to produce conditioned, filtered and controlled air.

We can design and install whatever is required for your facility - Enclosure, air, electrics, plumbing, flooring, extraction, benches, furniture etc.

We can provide free site surveys and prepare outline drawings and quotations.

Project control included full CDM planning, dealing with building control or HSE requirements where necessary and arranging validation if required.

Contents

Hardwall & Modular Enclosure 4-5

Softwall Areas & CMM Rooms 6-7

Laboratory Fit Outs & Furniture 8

17Associated Works to Complete Your Facility 9

Particle Size & Clean Room Classification 10-11

Other Stodec Products & Systems 12

ContentsContents & Services



Designing controlled environment enclosures has to start with a clear definition of the essential conditions to be created and manufactured based on client requirements.

The space available, or required, and the budget restraints for both installation and for cost of operation will then guide the best options for the fabric and layout of the area.

HARDWALLIf the room will fit into an existing building then lining existing walls can be considered - either with full panelling or with a PVC, food-safe, or fully vinyled surface.

Most facilities are stand-alone so the room envelope fabric is constructed from our steel-faced wall and ceiling panel systems which are finished, sealed and insulated to match the room environment.

MODULARWhere space allows or where modification and change is likely then the fabric can be delivered and built with prefinished modules to speed installation and to make change or relocation easier.

Hardwall & Modular Rooms

Hardwall & Modular Rooms

01727 840 594 01727 843 368



ContentsHardwall & Modular Rooms

CASE STUDYWatson Marlow Ltd

The world leader in Peristaltic Pumps and fluid path technology built a completely new manufacturing facility for their silicone tube production.

This included a 900m2 cleanroom with change facilities, transfer hatches and a mezzanine platform supporting the plant.

The Class 7 room was manufactured with modular wall and ceiling panels and the walls and airhandling plant are designed to allow for the room to increase by a further 250m2 when required for increased production.

WALLS• Prefabricated panel systems in powder coated

steel, stainless steel, melamine, vinyl, Trespa or GRP

• Free-standing, structural or used to line walls

• Minimal on-site build time

• Adaptable on-site for last minute additions and alterations

• Relocatable and reusable

• Walk-on ceiling support capability

• Fire rated cleanroom systems

• Sound rated cleanroom systems

CEILINGS• Suspended - from existing structure, plastic-faced

or steel push-in tiles

• Suspended - from our own installed steel structures

• Self-supporting and walk-on systems

• Plenum ceilings (full filter or partial filter)

• Solid panel and PVC plank ceilings



Softwall Areas

Our softwall modules are built with an aluminium frame, assembled on-site and fitted with see-through strip curtains.

Ceilings are usually wide span panels with fan filter units and lights mounted under.

Usually, these provide up to Class 8 or 9 conditions. Temperature control can be included with an air conditioning or heating unit.

Surrounding airflows, dust or fumes need to be considered as the enclosure is not a sealed and air-tight unit.

This type of structure is particularly useful for the provision of clean air in the following cases:

• Where a process needs temporary cover

• To provide clean air to just one part of a production line

• As a temporary test unit prior to needing or deciding on a permeant facility

• To produce an easily movable, self-contained clean air space

• To meet an urgent request when time is short

Softwall Areas

01727 843 36801727 840 594



ContentsCoordinated Measuring Machine Rooms

Coordinated Measuring Machine Rooms

These are key areas requiring very close temperature control and may also need humidity and particulate control to ensure that the accuracy and measurement is not affected by the thermal movement or other contaminants.

The CMM rooms are often enclosing high or bulky machines and may need insulated and fire rated enclosures.

We use our steel-faced, insulated core panels with single or double glazed units and have installed areas up to 8m high for major aerospace and precision engineering customers.

Air handling and control plant is designed to meet the particular requirements of each individual CMM area.



Laboratory Fit Outs & Furniture

01727 840 594

We have completed many bench, cupboard and workplace installations to provide high-quality laboratory facilities.

Our range includes Trespa, stainless steel, laminated and composite surfaces, sinks and framework and can be tailored to fit your space and your workplace requirements.

Laboratory fit out can be part of a new facility or an update of an existing area.

Associated building, plumbing and electric work including data cabling, lights and power needs can all be included as part of the contract.

All cleanroom, laboratory or research facilities need to be fitted and furnished with suitable services, plant, equipment, flooring, fixtures and furniture.

We provide the best quality installation and materials to fully finish your facility to the highest standards.

Laboratory Fit Outs & Furniture

01727 843 368



ContentsAssociated Works to Complete Your Facility

If you require your cleanroom, laboratory or research facility to be fitted and furnished with suitable services, plant, equipment, fixtures and fittings, we can provide quotations for high quality materials and installation to fully finish your facility.

Lighting

• Recessed or surface mounted

• Top or bottom opening

• Teardrop units for full filter ceilings

• Explosion and moisture proofs

• Yellow and red lighting

Air-conditioning and filtration plant

• Recirculating and total loss systems

• Temperature and humidity control to customer specifications

• Special applications for rooms with high heat loads or cooling loads

Flooring

• Seam welded vinyl

• Epoxy resin

• Antistatic

• Perforated raised access floors

• Biological protection floors

Operation Equipment

• Laminar flow benches

• Step-over units

• Transfer hatches

• Extract systems

Associated Works to Complete Your Facility



Common Contaminant Particle Sizes

Particle Sizes in Perspective

...then this represents a 10 micron particle...

If this dimension represents the diameter of a human hair, 100 microns...

...and this represents the a 0.5 micron particle.

Particle Sizes

01727 843 36801727 840 594

Visibility



ContentsClean Room Classifications

CONTROLLED ENVIRONMENTS TO BS 5295:1989

BS ClassMaximum particle size/m3

(Equal or above stated size)

Max. area per sampling

position (m2)

Minimum pressure differ-ence (+) (Pa)

Approx. EU GMP equiv.

at 0.5um size

Approx. Fed Std 209E equiv. at

0.5um size

Approx. ISO 14644-1 equivalent

0.5μm 0.5μm 10μm 25μm

Between clas-sified area & unclassified

area

Between clas-sified area & adjacent

area of lower classification

C 100 35 <1 NS NS 10 15 10 1 3D 1000 350 <1 NS NS 10 15 10 10 4E 10000 3500 <1 NS NS 10 15 10 A 100 5F NS 3500 <1 NS NS 25 15 10 B 100 5G 100000 35000 200 <1 NS 25 15 10 1000 6H NS 35000 200 <1 NS 25 15 10 1000 6J NS 350000 2000 450 <1 25 15 10 C 10000 7K NS 3500 K 20000 4500 500 50 15 10 D 100000 8L NS NS 200000 45000 5000 50 10 10 9M NS NS NS 450000 50000 50 10 NA

CONTROLLED ENVIRONMENTS TO U.S. FEDERAL STANDARD 209E

FS Classification Maximum particle size/3 (Equal or above stated size)Approx. BS 5295:1989 equivalent

Approx. EU GMP equivalent

gradeEnglish

Sl English 0.1μm 0.2μm 0.3μm 0.5μm 5.0μm M 1.5 1 1240 265 106 35.3 NA C 3M 2.5 10 12400 2650 1060 353 NA D 4M 3.5 100 NA 26500 10600 3530 NA F(E) B(A) 5M 4.5 1000 NA NA NA 35300 247 H(G) 6M 5.5 10000 NA NA NA 353000 2470 J C 7M 6.5 100000 NA NA NA 353000 24700 K D 8

MANUFACTURE OF STERILE PRODUCTSANNEXE 1 TO THE EU GUIDE TO GOOD MANUFACTURING PRACTICE (EC) 1997

EU GMP Classifi-cation

At rest In operation Approx. Fed Std 209E equivalentApprox. BS 5295:1989 equivalent

Approx. ISO 14644-1 equiv-

alent Maximum permitted number of particles/m3 SI English 0.5μm 5.0μm 0.5μm 5.0μm A 3500 0 3500 0 M 3.5 100 F(E) 5B 3500 0 350000 2000 M 3.5 100 F(E) 5C 350000 2000 3500000 20000 M 5.5 10000 J 7D 3500000 20000 NS NS M 6.5 100000 K 8

CONTROLLED ENVIRONMENTS TO BS EN ISO 14644-1 (1999)

ISO Class

Max. No. of particle/m3

(Equal or above stated size)

Approx. equiva-

lent BS 5295Approx. equiva-

lent FS 209EApprox. equiva-

lent EU GMP

0.1μm 0.2μm 0.3μm 0.5μm 1.0μm 5.0μm 1 10 22 100 24 10 43 1000 237 102 35 8 C 1 M1 54 10000 2370 1020 352 83 D 10 M2 55 10000 23700 10200 3520 832 29 E/F 100 M3 5 A/B6 1000000 237000 102000 35200 8320 293 G/H 1000 M4 57 352000 83200 29300 J 10000 M5 5 C8 3520000 832000 293000 K 100000 M6 5 D9 35200000 8320000 2930000 L

A wide range of different standards are used to specify the performance level that your clean facility should meet. Unfortunately it is not easy to compare one standard with another as they will often have different conditions applied to their methods of management, e.g. there will be differences between the number and position of samples to be taken, the pressure requirements between rooms, the relevance of certain size particles, the air change rates to be applied, etc.

The most common standards are US Fed 209E, BS 5295, EU GMP (Good Manufacturing Practice), or BS EN ISO 14644-1 (1999).

The tables below give an outline guide to the approximate comparisons between these standards but you cannot necessarily assume that meeting one standard also meets another. We are able to guide you further when you have a particular project to consider and design your installation to the appropriate cleanroom standard.

Clean Room Standards Room classifications can be specified in the following alternative states:

1 - As Built - With no equipment, personnel or product. Newly built area.2 - At Rest - With equipment installed but no personnel present.3 - Operational - With equipment installed and operating with personnel present.

NB: Approximate comparisons between different standards are shown but you cannot necessarily assume that meeting one standard also meets another


Other Stodec Group Products & Catalogues

Other Stodec Products & Catalogues

catalogue

for environments that work

Design & Installation Engineering

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Buy online at:

www.stodec.com

Catalogue

Products &Services

2015- 2016

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StodexStructural Floors

MEZZANINES

RAISED STORAGE AREAS

PLANT SUPPORT PLATFORMS

RAISED OFFICES

from the experts with more than

30 YRS experience

DON’T RELOCATE - USE YOUR EXISITING PREMISES TO THE FULL

INCREASE YOUR: SPACE • WORK AREA • PROPERTY VALUE

Prices for many components are on the

‘BUY ONLINE’ section of our website

www.stodec.com

FULL LIST OF BROCHURES ON OUR

WEBSITE FREQUENTLY UPDATED

Our website download section also includes

useful data on storage design and use as

well as guidance on health & safety in the

works and warehouse

w: www.stodec.com e: [email protected]

ST ALBANS9 The Metro Centre, Ronsons Way

St. Albans AL4 8QTt: 01727 840594 f: 01727 843368

MILTON KEYNES8 James Way, Denbigh West

Milton Keynes MK1 1SUt: 01908 270011 f: 01908 270022


the a cleanroom company company ltd - stodec company ltd ... precision engineering, pharmaceutical...

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