Biopharmaceutical Steam Products

High purity systems and components for the biopharmaceutical industry

Indianapolis ● Chicago ● San Juan www.hollandapt.com

800-800-8464

Your perfect partner for high purity systems

The design of high purity steam and water systems can be a complex and

highly involved discipline. To ensure that your system is designed to current

good manufacturing practice (cGMP), you need a partner who understands

your process and can support you through the life of your project.

With over 100 years experience in system design, a global network of

dedicated technical specialists and one of the broadest range of equipment

in the industry, Spirax Sarco is the natural partner to help design and

provide solutions and components for your high purity system.

• Support and advice on high purity system design

• Pure /clean steam generation and water for injection (WFI) production

• Sanitary pressure control and instrumentation

• Pure and clean steam trapping

• Sanitary ancillary products – including ball valves, steam separators,

check valves, sight glasses and sample coolers

• Steam quality testing and system validation

Validation and compliance

To meet the growing needs of the FDA and other governing bodies, each

high purity product we manufacture has been designed in accordance to the

relevant industry standard and is available with the required certification.

As you would expect from a world-class manufacturing company, we maintain

an ISO 9001 certified quality system.

• Material test certification

• FDA / USP class VI approved material certification

• Surface finish certification

• Welding procedures and qualifications

We also offer a complete validation service on our range of packaged purified

water systems, multi effect stills and clean/pure steam generators:

• Factory acceptance tests (FAT)

• Site acceptance test (SAT)

• Installation qualification (IQ)

• Operational qualification (OQ)

• Performance qualification (PQ)

Steam quality testing

Standards HTM 2031, HTM 2010 and EN 285 set specific

steam quality - dryness, as well as superheat and non-

condensable gas content, properties to ensure optimum

autoclave sterilisation. These criteria must be validated

on a regular basis.

Due to our in-depth knowledge in this area, Spirax Sarco

are well positioned to take on this validation requirement.

Pure steam loop - A single point of supply

Generation1. Purified water systems2. Multi-effect distillation system3. Vapour compression system4. Pure steam generator5. Clean steam generator

Sanitary pressure control6. STERI-TROL sanitary control valve7. Sanitary pressure regulator8. SVL488 sanitary safety valve9. Sanitary instrumentation (various)

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Pure and clean steam trapping10. BT6 steam trap11. BTM7 and BTS7 steam trap12. BTD52L steam trap

Sanitary ancillary products13. M70i and M80i ball valve14. CS10 steam separator15. AVM7 air vent16. CVS10 check valve17. SGS10 sight glass18. SSC20 sample cooler19. Clean humidification

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Case study 1: Pure Steam Generator (PSG) complete with validation

Issue: To comply with FDA approvals, biopharmaceutical facilities

must meet the specified validation requirements.

Each piece of equipment, including PSG and water for

injection (WFI) distillation equipment must have its own

IQ (Installation Qualification), OQ (Operational Qualification)

and PQ (Performance Qualification) documented to facilitate

formal validation of the system.

Problem: Often this required documentation is not completed until the

equipment has been fully manufactured and delivered to site,

resulting in additional inspection resource and delayed on-site

validation time.

The solution: Spirax Sarco is able to document and compile the IQ, OQ

and PQ, in a format that can be validated, concurrently with

the manufacture of our range of PSG’s and WFI distillation

systems. Enabling the required documentation to be

delivered to site with the system for immediate incorporation

into the overall site validation programme.

Spirax Sarco high purity products

Spirax Sarcos’ range of high purity products are designed and manufactured to the latest version of ASME BPE, ensuring all products meet the latest requirements of the Biopharmaceutical industry.

For in-depth details of products please consult Spirax Sarcos’ high purity product handbook.

Sanitary control and instrumentationAccurate control is essential for the successful operation of your process. Spirax Sarco offers a wide range of electrically and pneumatically actuated control valves as well as direct acting pressure regulators.

A variety of sanitary instrumentation is also available to complete your control loop as well as sanitary safety valves to protect you system.

GenerationA comprehensive range of Clean and Pure steam generators and WFI distillation units designed and manufactured to cGMP, ISPE, ASME BPE and FDA guidelines, to produce steam and water in compliance with International Pharmacopia.

Case study 2: Elan Pharma International Ltd

Issue: Project constraints due to the large amount of microbiology

testing required in a Sterile Fill Finish Facility made Elan Pharma

International re-think its previous testing procedure that used its

microbiology department.

The solution: Spirax Sarco engineers test the clean steam system for

dryness fraction, non-condensable gases and superheat. These

parameters help determine the purity of the steam, which in turn

ensures Elan is in compliance with regulatory requirements. The

Spirax Sarco testing regime for Elan complies with technical

memorandum HTM 2010.

"We’ve been really pleased with the service so far," says Mr.

Eoghan Gallagher, Project manager at Elan. "We need to keep

testing the steam on a quarterly basis and we will keep using

Spirax Sarco to do so, probably for a number of years."

Result: Elan Pharma International Ltd has simplified its clean steam

quality testing procedures by bringing in Spirax Sarco to

undertake regular testing to help the company achieve optimum

process control.

Sanitary ancillary productsTo complete your high purity system, Spirax Sarco offers a broad range of ancillary products, including sanitary ball valves, check valve, sample coolers and steam separators.

Custom sanitary systems are also available, including pure steam humidifiers, sanitary heat exchangers and filter housings.

Pure and clean steam trappingA comprehensive range of thermodynamic and thermostatic steam traps developed specifically for clean and pure steam applications. Including traps that minimise condensate back-up for critical steam-in-place applications.

Some products, services or solutions may not be available in certain marketsSPIRAx ULTRAPURE

1050 CORPORATE AVENUE

UNIT 114

NORTH PORT, FL 34289

t: 941.473.2422

f: 941.473.2144

www.spiraxultrapure.com

Regional sales offices

NortheastSpirax Sarco, Inc.7760 Olentangy River RoadSuite 120Columbus, OH 43235Phone: (614) 436-8055Fax: (614) 436-8478

SPB1053 Printed in USA 3/07. Copyright 2007 Spirax Sarco, Inc.

Mid AtlanticSpirax Sarco, Inc.4647 Saucon Creek RoadSuite 102Center Valley, PA 18034Phone: (800) 251-7676Fax: (800) 996-3232

SoutheastSpirax Sarco, Inc.115 Atrium WaySuite 118Columbia, SC 29223Phone: (800) 883-4411FAx: (803) 865-0459

MidwestSpirax Sarco,Inc.1500 Eisenhower LaneSuite 600Lisle, IL 60532Phone: (630) 493-4525Fax: (630) 724-9176

SouthwestSpirax Sarco, Inc.203 Georgia AvenueDeer Park, Tx 77536Phone: (281) 478-4002Fax: (281) 478-4615

WestSpirax Sarco, Inc.1930 East Carson StreetSuite 102Long Beach, CA 90810Phone: (310) 549-9962Fax: (310) 549-7909

SPIRAx SARCO, INC.

1150 NORTHPOINT BLVD.

BLyTHEWOOD, SC 29016

t: 800.883.4411

or: 803.714.2000

f: 803.714.2222

www.spiraxsarco.com/us

Indianapolis ● Chicago ● San Juan www.hollandapt.com

800-800-8464

Biopharmaceutical Steam Products

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