sealing elements - etansari · rect elastomer or perfluorocarbon uti-lized in high purity sanitary hygenic seals where critical pure water, process fluids (both ambient and hot),

sealingelements

• High pur i ty

FDA and USP c lass V I

compl iant O-r ings

• High pur i ty e lastomers

for pharmaceut ica l ,

b iochemical and food

industr ies

ERIKS nvBoombekelaan 3,B-2660 Hoboken, tel.: 03/829.27.20fax: 03/[email protected]

ERIKS saAvenue J.E Lenoir 2a1348 Louvain-La-Neuvetél. : 010/48.35.75fax : 010/[email protected]

ERIKS sarl52, avenue des Frères-Lumière BP 151F-78196 Trappes cedexTel. +33 1 / 34 82 10 00Fax +33 1 / 34 82 10 [email protected]

ERIKS bvVoormeer 33Postbus 280, 1800 BK AlkmaarTel. +31 72 / 514 15 14Fax +31 72 / 515 56 45e-mail: [email protected]

ERIKS pte ltdBlk 1 #02A-13/16Pasir Panjang Road - Pasir Panjang DistriparkSignapore 118480Tel. +65 272.24.05Fax +65 274.17.06e-mail: [email protected]

www.eriks.comwww.o-ring.info

2

HIGH PURITY FDA & USP COMPLIANT O-RINGS / HIGH PURITY ELASTOMERS FOR PHARMACEUTICAL, BIOCHEMICAL AND FOOD INDUSTRIES

1. General introduction 3

2. Classes of use FDA-USP 4

3. Introduction to FDA-USP concept 5

4. O-rings FDA-USP 6

5. FDA-USP compounds, O-rings and mouldings 8

6. High Purity seals card 9

7. Approved compounds for potable water 10

8. The High Purity Kalrez® O-ring concept 12

9. Elastoguard Microbiological growth - problems and solutions 16

10. Addendum - legal institutes 18

C o n t e n t

3


1 . G e n e r a l i n t r o d u c t i o n

Efficiently protecting process inte-grity is a challenge for all pharam-ceutical manufacturers.

Today’s pharmaceuticl and biophar-maceutical manufacturing processesrequire the efficient handling of a widerange of process fluids under varyingconditions of temperature and pres-sure. From basic chemical storage andhandling to manufacturing and wastemanagement, process lines and vessels must be resistant to a varietyof fluids. Many of these are toxic and corrosive,including raw materials, intermediatechemicals, active pharmaceuticalingredients (APIs), cleaning/sterilizingagents and by-products. What’s more,during sterilization, temperatures canreach up to 160°C. Whatever thefinished product, tablet, capsule, ointment or liquid suspension, thefluid-handling system plays a criticalrole.

Seal performance is paramount

Experience has shown that the wea-kest links in manufacturing processesare often the seals in couplings, flanges and other connection points inpiping and equipment.Degradation of these joint seals canresult in:

• contamination of the final or interme-diate products during manufactureand/or

• leakage that may require a processshutdown.

Even with the availability of specialtyelastomers such as Viton® fluoroela-stomer (FKM) or chemically-inertTeflon® polytetrafluoroethylene (PTFE),the problems of seal failure have notbeen solved. With increased aware-ness and stricter guidelines regardingproduct and environmental safety,selection of proper sealing materials iscritical for maximizing production up-time. High-performance sealing materials should offer the chemicalinertness and cleanliness of PTFE without sacrificing the resilience andassociated sealing benefits of true elastomers.

Customer needsERIKS is focused on meeting customer needs and on assisting solving customer problems.

To respond to the higher needs ofpurity in pharma, biochemical and foodindustries, ERIKS developed a range of‘high purity’ elastomers, described inthis leaflet.

We developed a ‘technical educationprogram on ‘legislation of FDA andUSP’ as well as on the theoretical andpractical issues of migration of rubber substances. More info on www. eriks.be.etoc

4


2 . C l a s s e s o f u s e F D A - U S P

2.1. FDA compounds

FDA CFR § 21.177.2600 sets the stan-dard for ensuring that foods are safeand sanitary; that human and veterina-ry drugs, biological products, medicaldevices are safe and effective.

FDA also ensures that these productsare honest, accurate and are informa-tively represented to the public.

CFR 21.177.2600 sets out the relevantregulations for ‘rubber articles inten-ded for repeated use’. These list theingredients that may form part of arubber compound. The list includeselastomers, accelerators, plasticisers,fillers, emulsifiers, etc.

There are also certain quantative limitations on different ingredients.

ERIKS FDA compounds are producedto meet class 1 for fatty foods. Thismeans that the ‘high purity’ carbonblack does not exceed 10%. All ourcompounds have been tested by anindependent certified lab in Germanyfollowing the class 1 rules in n-hexaneat reflex temperature. Certificates on demand.

2.2. USP compounds

USP class VI compounds are control-led by United States Pharmacopeia(USP), a non-governmental organisa-tion that promotes the public health byestablishing state-of-the-art standardsto ensure the quality of medicines andother health care technologies.

The standards are published in theUP-NF which is officially recognised inFDA act (21 usc § 321 et seq.).

USP class VI compounds haveundergone tests to: • cytotoxicity• hemolysis• pyrogenicity• sensitisationSome elastomers are also formulatedfollowing the European Pharmacopeia.

5


3 . I n t r o d u c t i o n t o F D A - U S P c o n c e p t

3.1. General information on FDA

Since many years ERIKS has a leadingrole in the production and marketing ofhigh quality seals.ERIKS has also developed a vast rangeof elastomeric compounds that are for-mulated to comply with the regulations issued by the ‘United StatesFederal Food and Drug Administration’(FDA). These regulations are stipulated inTitle 21, chapter 1, subchapter B, sec-tion 177.2600 of the ‘Federal food andCosmetic Act’.These regulations define which rubberpolymers and compounding ingredientscan be used in rubber articles, intendedfor repeated contact with food and preventing the use of dangerous substances that might cause cancer.

3.2. Types of FDA

Two important types (class 1 and class 2)of FDA exist, depending on the percent-age of furnace carbon/black that isadded to the compound.Class 1: for edible oils, greasy media;Class 2: for aqueous media.

3.3. Certification

ERIKS guarantees the ‘conformity’ by:• strict production methods,• an FDA-sticker which is put on the

packaging,• a certificate of conformity which can

be obtained (on payment) with everydelivery.

In general ERIKS guarantees that theFDA-materials are ‘FDA-compliant’which means they are composed withingredients according the FDA-regu-lations under 1.2. on this page.

3.4. Migration tests FDA

Some compounds have been testedby independent laboratories (for exam-ple ‘Rapra’ in England).Rubber articles intended for repeateduse in contact with aqueous food shallmeet the following specifications: ‘Thefood-contact surface of the rubberarticle in the finished form in which it isto contact food, when extracted withdistilled water at reflux 20 milligramsper square inch during the first 7 hoursof extraction, nor to exceed 1 mil-ligram per square inch during the suc-ceeding 2 hours of extraction’.

Rubber articles intended for repeateduse in contact with fatty foods shallmeet the following specifications: ‘Thefood-contact surface of the rubberarticle in the finished form in which itis to contact food, when extractedwith n-hexane at reflux temperature,shall yield total extractives not toexceed 175 milligrams per square inchduring the first 78 hours of extraction,nor to exceed 4 milligrams per squareinch during the succeeding 2 hours ofextraction’.

3.5. USP

USP class VI was especially develo-ped for the pharmaceutical industry. This information has been carefullyprepared to help in selecting the cor-rect elastomer or perfluorocarbon uti-lized in high purity sanitary hygenicseals where critical pure water,process fluids (both ambient and hot),and SIP environment exist.The intention is to consider the differ-ent uses, applications and conditionsto determine the most favorable gas-ket material for each application. Thefollowing criteria is used in determiningcorrect sanitary gasket materials.

• USP Pharmacopoeia Class VI-XXIICertification

• Cytotoxicity Criteria• CFR Title 21 Section 177.1550• CFR Title 21 Section 177.2600• Traceability: Lot and Batch• Certification: Lot and Batch• ASME-BPE Standards• USD Standards• 3-A Sanitary Standards• Current Good Manufacturing

Practices (CGMP)• Manufacturer data and specifications• Consultation with various pharmaceu-

tical users

The gasket materials considered areTef-Steel® (Teflon/Stainless Steel),Teflon® (PTFE), Silicone (platinum cured),Viton®, EPDM and Buna-N.

The 3 main goals are:• To protect products from contamina-

tion, spalling, particulates and TOCsresulting from the use of impropersanitary gasket material.

• To protect facilities from unnecessarydowntime associated with sanitarygasket failure and replacement fromuse of improper gasket material.

• To provide a standard of consistencyof sanitary gaskets selection betweenmultiple facilities.

Most decisions driving gasket typeselection are based on chemistry, tem-perature, exposure limits, USP, FDAqualifications, and curing methods.

6


4 . O - r i n g s F D A - U S P

4.1. Introduction

Since many years ERIKS has a leading role in the production and marketing of highquality seals.ERIKS has also developed a vast range of elastomeric compounds that are formu-lated to comply with the regulations issued by the ‘United States Federal Food andDrug Administration’. These regulations are stipulated in Title 21, Chapter 1, subchapter B, section177.2600 of the federal food and cosmetic Act.

4.2. Types of FDA 177.2600

Two important classes (class 1 and 2) of FDA 177.2600 exist, depending on thepercentage of furnace black that is added to the compound.Class 1:for aqueous media, edible oils and greasy media (max. 10% furnace black)Class 2:for aqueous media only (max. 50% furnace black)

4.3. Migration tests foll. FDA 177.2600

FDA regulations stipulate that FDA compounds have to be tested on migration.Indeed, rubberingredients tend to migrate into the system when brought in contactwith media. Extraction of these particles is stipulated for class 1 and 2 FDA compliant elastomers.Most ERIKS compounds are tested by independent labs and comply with thesemigration values (see certificate).

4.4. USP class VI-XXII

USP class VI stipulates that cytotoxicity-testes are carried out.Our USP class VI compounds are also conform 3A, USDA, FDA and NSF51 regulations.

Ask for our FDA-USP

technical manual

7


4 . O - r i n g s F D A - U S P

4.5. Certificates

For every delivery we can send you following information on request:• FDA sticker on the packaging• FDA certificates with migration values• USP sticker on the packaging

4.6. Extra Service

ERIKS offers you following extra services:• Extra postcuring for optimal vulcanisation degree• Cleaning with dionised water• Custom packaging• Barcoding

C e r t i f i c a t e a n d d a t a s h e e t e x a m p l e s :

CERTIFICATE OF CERTIFICATION

Your order:

We hereby certify that th

e elastomer compounds EPDM, platinum

cured silicone and Viton® from which we manufacture our parts

have been tested by and certified by the National Sanitation founda-

tion to be in compliance with the FDA Code of Federa Regulations

for rubber a

nd rubber-lik

e material under Title

21, Paragraph

177.2600 and also meet the crite

ria of the USP Class VI m

aterial

classification of the 3-A sanitary standards, USDA and Standard 51

of the N.S.F.


e elastomer compounds Buna-N peroxide

cured silicone from which we manufacture our parts have been tes-

ted by and certified by the National Sanitation Foundation to be in

compliance ith the FDA Code of Federal re

gulations for rubber and

rubber-like material under Title 21, paragraph 177.2699 and also

meet the crite

ria of the USP class I m

aterial classification of 3-A

standards, USDA and Standard 51 of the N.S.F.


e Teflon and Tefsteel resins fro

m which our

parts are manufactured have been tested in our labaratory and are

found to be in compliance with the FDA Cofe of Regulations for

Teflon and Fluorocarbon resins under Title 21, paragraph 177.1550

for use in contact with food and also meet th

e criteria of th

e USP

Class VI material classification of th

e 3-A Sanitary Standard.

8


Table 1: Compounds FDA

Compound Quality Class Hardness Migration Colourtested

Viton® 514670 Viton® 1 70 Yes blackViton® 514680 Viton® 1 80 Yes blackViton® 514690 Viton® 1 90 Yes blackViton® 514672 Viton® 1 70 Yes whiteViton® 514674 Viton® 1 70 Yes blueViton® 514694 Viton® 1 90 Yes blueViton® 514676 USP class VI Viton® 1 70 Yes whiteEPDM 559273 USP class VI EPDM 1 70 Yes blackEPDM 559274 USP class VI EPDM 1 70 Yes whiteEPDM 559270 EPDM 2 70 Yes blackEPDM 559272 EPDM 1 70 Yes whiteNBR 366470 NBR 1 70 Yes blackNBR 366480 NBR 1 80 Yes blackNBR 366490 NBR 1 90 Yes blackNBR 366472 NBR 1 70 Yes whiteHNBR 886972 HNBR 2 70 Yes blackSil 714748 Silicone 1 40 Yes redSil 714747 Silicone 1 40 Yes transl. Sil 714742 Silicone 1 40 Yes whiteSil 714767 Silicone 1 60 Yes transl.Sil 714768 Silicone 1 60 Yes redSil 714762 Silicone 1 60 Yes whiteSil 714787 Silicone 1 80 Yes transl.Sil 714788 Silicone 1 80 Yes redSil 714782 Silicone 1 80 Yes whiteSil 714001 USP class VI Silicone 1 70 Yes transl.Sil 714002 USP class VI Silicone 1 70 Yes transl.

1. Moulded O-rings, class 1(less than 10% furnace black)

These can be produced in all possibledimensions up to diameter 1400 mminternal. Table 1 shows our standardprogramme FDA compliant com-pounds which can be produced in afew days.All O-rings are produced following DIN3771 part 1-ISO 3601/1.

Note:• Other FDA compounds in other

hardnesses or qualities are alsoavailable in smaller quantities butwith a slightly longer delivery time.

• USP XXII, class VI O-rings availablein Silicone translucent. Other compounds on request.

• Black compounds are produced withless than 10% high purity furnaceblack.

5 . F D A - U S P c o m p o u n d s , O - r i n g s a n d m o u l d i n g s

Table 2: Compounds Vulc-O-ring FDA or USP

Compound Quality Class Hardness Migration tested Colour366185 NBR 1 75 Yes black514152 Viton® 1 75 Yes black559187 EPDM 1 75 Yes black714203 Silicone 1 75 Yes red329303 Neoprene® 1 75 Yes blackTeflex / Silicone * FEP/Silicone 1 - Yes red714006 (3A) Silicone 1 75 Yes redTeflex / Viton® * FEP/Viton® 1 - Yes blackTeflex/EPDM FEP/EPDM 1 - Yes white

* : FEP encapsulated in FDA 177.1550 and USP XXII, class VI

Table 3: Kalrez® FDA or USP

Compound Quality Class Hardness Migration tested ColourKalrez® 6221 FFPM 1 70 Yes whiteKalrez® 6230 FFPM 1 75 Yes black

2. Vulc-O-rings FDA class 1 (less than 10% furnace black) and moulded O-rings

Vulc-O-rings are produced in smallquantities. Inside diameter from 30 mm up to 5.000 mm in differentcross section diameters from 1,78 upto 25 mm. For silicone up to 40 mmdiameter. No chemical additif is addedin the bonding of the core-ends.Datasheet on request.

3. Kalrez®

The ultimate pure compound for SIPand CIP applications in pharma andfood up to 275°C. FDA and USP class VI compliant.

Note: All O-rings are produced foll. DIN3771 part 1 - ISO 3601/1

9


6 . F D A - U S P c o m p o u n d s , H i g h P u r i t y S e a l s C a r d

HIGH PURITY SEALS CARD

PRODUCT SERVICES TECHNICAL SUPPORT PACKAGING CERTIFICATES INVENTORY SYSTEMS

O-rings Application Engineering One by one FDA 177.2600 Kanban

Oil seals R & D Clean Room FDA 177.1550 Local branch

PTFE seals Product Search Barcode USP class VI In plant shop

Rubber parts Technical Data Your ID number USDA Express production

Clamp seals Independant labs FDA or USP labels NSF Kittingon packaging

Hydraulic seals KTW-BGVV e-business

Rubber profiles KIWA Just-in-time

WRC-ACS EDI

Cytotoxicity testing

3A standards

Namsa

Full Traceability

Ask for our High-Purity

Triclovergaskets handbook

10


7 . A p p r o v e d c o m p o u n d s f o r p o t a b l e w a t e r

Compound Code Approval Approved Shore HardnessNBR 366320 DVGW-W270-25/+100°C KTW

NSF61 ACS NF 70FDA 177.2600WRC WRAS FDA 177.2600 DIN-EN 549 gas

EPDM (PEROX) 559970 WRC WRAS for 85°C-55/+150°C ACS NF

KTW for 90°CNSF61 FDA for 82°C 70 DVGW-W270 for drinking waterEN681 WBFDA 177.2600

FKM (Viton®) 714320 WRC WRAS-15/+200°C FDA 177.2600

KTW DVGW 70NSF61ACS DIN-EN549 for gas

SILICONE (VMQ) (*) (**) 514320 WRC WRAS for 85°C-60/+220°C KTW for 90°C

NSF61 ACS NF FDA 177.2600 70 DVGW-W270 FDA 177.2600

• Many ERIKS compounds are produced following international norms (see addendum).• Quality security in all production sites worldwide.• EPDM 5599 to compound is specially compounded with very low lubrificant % so that tensioncorrosion on plastic parts

is excluded.• Application in valves, fillings, couplings, fluidconnectors, pipesystems, etc.• Optimal lifetime due to intensive compound research.

ERIKS compounds for potable water

Food / Pharma Potable water Potable water Potable water Potable water Potable waterFDA KTW ACS WRAS NSF61 DVGW

W270EPDM 55111 x x x x x xNBR366320 x x x x x xFKM814320 x x x xSilicone714320 x x x x x x

11


EPDM 559970 PC FDA - Technical Data Sheet

1. IntroductionThe ERIKS compound EPDM 559970 PC FDA is a

2. Product Description

3. Physical Properties

Chemical Composition :Physical form :Color :Storage stability :

Terpolymer ethylene / propyleneO-rings/mouldingsBlackmax. 10 years

Test Method Norm Test ValuesHardness DIN 53519 70° ± 5° IRHDSpecific Weight ASTM D 1817 1,13Elongation at break ASTM D 412 C 160%Tensile Strength at break ASTM D 412 C 16 N/mm2

Compression Set22h/150°C ASTM 395B 9%3.000h/110°C DIN ISO 815 (in water) 10%Change in air / 70h/100°C ASTM D 471Hardness change -1°Volume change +1,5%Weight change +1%

4. Temperature Resistance• -55° to +150°C• TR10 (low temp. resistance): -36°C

5. Chemical ResistanceAlkali : very goodAlcohol : goodEthers : fairFats : unsatisfactoryHydrocarbons : unsatisfactoryEsters : unsatisfactoryAir : very goodOils : unsatisfactoryOzon : excellentWater : excellentSteam : good

up to 130°

6. AdvantagesVery low compression set

7. Other Information• In compliance with:

ACSDVGW-W270EN 681-1following FDA 21 CFR 177.2600KTWNSF 51 and 61WRC

7 . A p p r o v e d c o m p o u n d s f o r p o t a b l e w a t e r

KTWKTW

ACSACS

NSFNSF

W-270W-270

WRCWRC

12


8 . T h e h i g h p u r i t y K a l r e z ® O - r i n g c o n c e p t

Kalrez® perfluoroelastomer partsimprove sealing for today’s processes

To meet the demand for greatersealing integrity while maintaining pro-cess purity, DuPont Dow Elastomershas a family of high-performance per-fluoroelastomer sealing materials uni-quely suited for pharmaceutical medi-cal manufacturing. Similar to PTFE incleanliness, heat and chemical resi-stance, Kalrez® has the resilience andcompressive strength that are charac-teristic for frequently used materialssuch as ethylene propylene polymers(EPDMs), fluoroelastomers (FKMs) andsilicone rubber.

With its combination of thermal/chemi-cal performance and rubberlike sealing ability, Kalrez® offers the phar-maceutical industry a new level of pro-tection against process contaminationand seal failure. Multi-purpose Kalrez®

seals increase process and equipmentflexibility and may make it possible tostandardize on a single seal materialfor all process environments.

Kalrez® compounds 6230 (black) and6221 (white) have been developed tomeet the unique sealing needs oftoday’s high-speed, fully automatedpharmaceutical and biopharmaceuticalmanufacturing processes. Kalrez®

parts are manufactured by DuPontDow Elastomers to ensure excellentquality, cleanliness and performance.

FDA and USP compliancy

The U.S. Food and DrugAdministration (FDA) confirmed thecompliance of Kalrez® 6221 and 6230for repeated use in contact with foodby Food Contact Nodification (FCN)000101. FCN 000101 was establishedthrough the FDA PremarketNotification Process for food contactsubstances as described in section409(h) of the Federal Food, Drug, andCosmetic Act 21U.S.C.348(h)) and isthe primary method by which the FDAauthorizes the use of food additivesthat are food contact substances. FCN 000101 requires materials to haveextractable levels less than 0.2 mg/in2.Kalrez® 6221 and 6230 have also beentested in accordance with UnitedStates Pharmacopeia Class VI (USPClass VI) and met those requirements.

13



Providing new standards of protectionagainst contamination and processinterruption.Unmatched resistance to aggressiveprocess chemicals.

Kalrez® is unmatched in its resistance toa broad range of fluids, manufacturingchemicals and aggressive waters com-monly used in pharmaceutical proces-ses. Its near-universal compatibility withover 1800 chemicals provides addedinsurance against exposure to propriet-ary or unknown ingredients.Acids, bases, solvents, and amines areamong the many corrosive chemicalsthat can be safely handled by Kalrez®seals. Kalrez® does not readily absorbliquids or solids present in the processstream. This protects against prematureseal failure due to swelling and loss ofmechanical properties while minimizingthe chance for product contaminationdue to chemical desorption of previouslyused chemicals from the elastomerseals.Each type of elastomeric seal can be dif-ferent depending on the grade of elasto-mer used as well as how it was formula-ted and manufactured. ‘Food Grade’ O-rings were obtained from the market-place and tested along with Kalrez® 6230and 6221 O-rings. It should be notedthat EPDM can be less resistant tomineral oils and aromatic hydrocarbons;silicones to solvents, oils, contentratedacids and dilute sodium hydroxide; andFKM to amines, some bases and alco-hols - depending on the formulation.Steam resistance can also be affectedby te grade and formulation used.

Extremely low extractablesKalrez® compounds contain fewerextractable materials (additives and fil-lers) than other elastomer seals. This sig-nificant difference reduces the risk ofproduct contamination by ingredientsleached from a sealed joint by the pro-cess flow. Total Organic Carbon (TOC)testing was used to show the levels oforganic extractables of the various mate-rials - Kalrez® parts are much more inertand clean than EPDM, silicone and FKMand very similar to PTFE.

600

550

500

450

400

350

300

250

200

150

100

50

0

TOC

(pp

m)

EPDM PTFEpt-silicone FKM Kalrez®

6221Kalrez®

6230

Kalrez® parts are much more inert and

clean then EPDM, silicone and FKM

and very similar to PTFE

Kalrez® 6221 and 6230 have extractable levels compared to PTFE

Kalrez® seals have low volume swell for better sealing functionality

Chemical Temp EPDM pt-Si FKM Kalrez® Kalrez®

(°C) 6230 6221Hexane 60 41 4 6 7 7Acetic Acid 100 135 1 199 3 19Acetone 50 -6 (*) 2 65 4 3Ethanol 60 -9 (*) 10 18 1 1Ethylene Carbonate 100 -3 (*) 0 64 0 0Toluene 100 155 50 86 6 6Glycerol 100 0 1 0 0 0Benzyl Alcohol 100 -7 (*) 2 10 1 1Ethyl Acetate 60 3 11 118 5 5Methanol 60 -5 (*) -2 (*) 67 1 120% Nitric 100 139 -2 (*) 309 1 1015% NaOH 100 0 0 10 1 1

(*) = < 0% volume swell (desorption)

EPA method 415; TOC tests performed on 1” sanitary seals, immersed in 50 ml ofsterile WFI at 100°C/24hrs. The solution was then diluted to 100 ml and analysis.

14



Delivering high-temperature stabilityand long-term elasticity

Properties:Kalrez® seals based on 6230 and 6221deliver outstanding performance inhigh-temperature service (up to260°C), even after exposure to aggres-sive chemicals and fluids. This meansthat Kalrez® provides a measure of safety, because it can comfortablyoperate in the middle of its temperatu-re range, rather than near its tempera-ture limit.

Sealing force retention (force underconstant stress) and compression setresistance are standard test methodsused to predict seal longevity. Kalrez®

seals have good compression set resi-stance in process fluids at elevatedtemperatures. In long-term testing ofsealing force, Kalrez® and FKM retaintheir sealing force better than bothEPDM and silicone at 140°C in hot air.FKM, however, can be limited in cer-tain fluid and steam conditions, depen-ding on the type and formulation.

Permanent deformation is the majordraw-back of seals made from PTFEand other non-resilient thermoplastics.Over time, these materials will undergocompression set or ‘creep’, and losetheir sealing force, even under modera-te temperatures and loads. As a result,thermoplastic gaskets must be re-tor-qued to maintain a leak-proof joint. Inmost cases, plastic seals cannot bereused because surface deformationand leak paths are permanent. Kalrez®

seals are made from a true elastomer;they maintain long-term sealing forceand are inherently resistant to perma-nent deformation or compression set.

Kalrez® 6230 retains its sealability in harsh conditions

Chemical Temp EPDM pt-Si FKM Kalrez®

(°C) 6230Acetic Acid 100 30 73 (*) 100 (*) 18Acetone 50 27 -2 -121 23Ethanol 60 28 5 14 26WFI (water) 100 68 (*) 81 (*) 94 (*) 40Benzyl Alcohol 100 54 (*) 21 27 22Ethyl Acetate 60 11 -3 -109 11Methanol 60 30 14 -84 2520% Nitric 100 62 (*) 99 (*) 49 215% NaOH 100 52 (*) 75 (*) 60 25

(*) = > 30%

15



A winning combination of cleanliness, integrity, quality andtraceability

For over 30 years Kalrez® has demon-strated its value in critical applicationsin the chemical process, semiconduc-tor, oil and gas recovery and aeros-pace industries. It has provided themost cost-effective solutions for high-performance sealing applicationswhere other seals have failed.

The entire Kalrez® manufacturing pro-cess, from base polymer to finishedseal, is controlled by one company,DuPont Dow Elastomers, under stric-test standards of quality control (ISO9001). This supply chain integration isunique among seal suppliers.

Formulations of Kalrez® tend to bemore polymer-rich than most othertypes of elastomer compounds, resul-ting in fewer ingredients to extract orleach into a process. Kalrez® assuresthat you get the same formulationevery time. Other elastomers haveseveral different grades or composi-tions. The combination of grade, filler,cure system, etc., can affect finishedpart performance (such as resistanceto steam). Finding a reliable supplierwilling to certify and provide documen-tation is important in the pharmaceuti-cal industry. Every Kalrez® seal is pack-aged individually, bar coded and 100%traceable back to raw materials.

Versatility increases flexibility andstandardization

A seal material with broad chemicaland temperature capabilities not onlyminimizes contamination and produc-tion problems, but also helps reducethe costs of routine maintenance andinventory control. Standardization on asingle sealing material may allow theexchange of equipment ‘mini modules’without the need to retrofit seals. Innew drug development programs oranalytical laboratories involving the useof unknown or proprietary fluids, asealing material with broad chemicalversatility can be especially useful.

16


9 . E las toguard Ant i -microb io log ica l g rowth - p rob lems and so lu t ions

The most significant breakthroughever in antimicrobial rubber technology

Imagine a situation where the rubbercomponents you incorporate into yourproducts; that form part of your pro-duction line; or you include in yourplant specification; require much lesscostly labour-intensive, routine inspection and sterilisation treatmentthan they currently demand.Imagine rubber that inhibits the growthof any micro-organism; bacteria, fungior algae and will deter it from contaminating or colonising its surface.Imagine the valuable, virtually uniquemarketing benefits and added valueyour products would enjoy.

Imagine the savings on downtime, lostproduction and maintenace costs. Just imagine how such a technicallyadvanced antimicrobial rubber couldimprove your products, your productivity, your profitability.

Elastoguard is not imagination.It is reality. Available now.

Products:• O-rings• Oilseals• Profiles• Sheets• Mouldings

Standard Elastoguard RX Types:• Elastoguard RX EPDM 70 black• Elastoguard RX Viton® 70 black• Elastoguard RX Silicon 70 red

Elastoguard explained

The growth of microbes on rubber surfaces can lead to foul odours, discolouration, the formation of mildewand slime.

Another potential effect of microbialcontamination on rubber componentsis serious surface degradation; aprocess that can significantly reducethe component’s operational lifespan.

Traditional protection against microbialcontamination involves thoroughlycleaning and washing with hot waterand detergent. Such cleaning proce-dures, especially where the rubbercomponents are sited in dificult toaccess locations, can be costly andtime consuming. What’s more, theseprocedures do not offer residual pro-tection against further contamination.

Very often, to ensure compliance withhealth and hygiene regulations, rubbercomponents are simply scrapped andreplaced, frequently at significantexpense.

Elastoguard is a pro-active antimicro-bial rubber that provides residual protection against microbial contami-nation, thereby dramatically reducingthe necessity for a traditional routinedecontamination service agenda.

Innovative patent pending technology

Developed by Milliken ChemicalSpeciality Elastomers, Elastoguard’ sinnovative patent pending technologycan be produced in a wide range ofspecialist compounds to meet a broadspread of needs. It incorporates a zir-conium phosphate-based ceramic,ion-exchange resin containing silver,which is acknowledged to be safe forhuman contact, and is recognised forits antimicrobial effectiveness against abroad spectrum of micro-organisms.Unlike most organic biocides,Elastoguard can be used in food con-tact situations and is designed for usein pharmaceutical and medical indus-tries.

17


9 . E las toguard Ant i -microb io log ica l g rowth - p rob lems and so lu t ions

Non-leaching

This antimicrobial agent forms an integralpart of the rubber compound. It is not simplya skin or liner, and therefore the antimicro-bial properties always remain active.Furthermore, any abrasion or wear to thesurface of the rubber actually increases theexposure of the silver and with it the efficacyof its antimicrobial qualities.

• Designed for use in pharmaceutical andfood processing technology, water treat-ment, medical equipment, beverage production and dispensing, and for closehuman contact.

• Provides effective microbial protectionagainst a broad spectrum of micro-organisms.

• Available in a wide range of technical rubber compounds.

• Can be incorporated as part of a customised compounding facility.

• Forms an integral part of the rubber compound, is durable and non-leaching.

• Does not affect colour stability of the compound.

• Has no taste. Contains no smell.• Non-toxic, non-flammable, non-corrosive.

Proven Elastoguard efficiency is supported by substantial technical data

Pictures show contaminated water droplets.The sample on the left, which is on anuntreated rubber surface, displays healthygrowth of fungi.The sample on the right, exposed to silverions in Elastoguard rubber is virtually clear ofany fungal contamination.

The effect of silver on healthy bacteria

Healthy bacteria DNA condenses on itself

Formation of electron dense

granulate

Cell wall decomposes

Elastoguard® NBR Rubber Exhibiting Safeand Durable Antimicrobial properties

NBR

NBR maximum Value®

Elastoguard® EPDM Rubber ExhibitingSafe and Durable Antimicrobial properties

EPDM

EPDM maximum Value®

C. albicans

Log of reduction* indicates the maximum value for the experiment

S. aureus

P. aeruinosa

K. pneumonicae

E. Coli

0 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00

C. albicans

Log of reduction* indicates the maximum value for the experiment

S. aureus

P. aeruinosa

K. pneumonicae

E. Coli

0 1.00 2.00 3.00 4.00 5.00 6.00 7.00 8.00Ask for our te

chnical

programme in your company

18


1 0 . A d d e n d u m

ADDENDUM

Certificates Application Standards Tests Legal Institution& Guidelines

WRAS Contact potable water BS 6920 Microbiological WRASBS 2494 Extraction (Water Regulation

Advisory Scheme)

ACS Contact potable water Afnor Microbiological ACSXP-P41-250 Synoptic documents (Accrediation Conformité

Sanitaire)

KTW Contact potable water BGVV Extraction BGVVCold, warm, hot water part 1.3;13 Smell and taste (Bundesinstitut für

Kunststoffe in Gesundlichen Lebensmittel Verbrauchersschutz und

Veterinärmedizin)

NSF Food and Sanitary NSF 51 Toxilogical NSFNSF 61 Microbiological (National Sanitation

Foundation)

FDA Food, Sanitary and Pharma White list Test white list FDACfr 21 Migration tests (Food and Drug

part 177.2600 for acquous and Administration)fatty foods

USP US Pharmacopeia USP class VI Cytotoxicity NAMSAEuropean Pharmacopeia Hemolysis TOXICON

PyrogenicitySensitisation

Documents

sealing elements - etansari · rect elastomer or perfluorocarbon uti-lized in high purity sanitary hygenic seals where critical pure water, process fluids (both ambient and hot),