The latex doctor

Particle counttesting forvinyl glovesCould you let me know aboutthe particle count testing of vinyl glovesfor a CleanroomClass10K Standard?

Ningsih Dharmawijaya

Fed.Std. 209E, "Airborne

ParticulateClassesfor Clean-rooms and Clean Zones" is thecontrolling document.This provides the allowable particulatecount andtotal particulateareaforall cleanroomlevels.

The control is on the particlesin the room and not on the individual protectivegear in the room.However, steps are taken to reduceparticulatesby choosinglow-particulateprotective garmentsanddevices.

IES-RP-CCOO5.2:"Gloves andFinger Cots Usedin Cleanroomsand Other Controlled Environments" is availablefrom the Institute of EnvironmentalSciences,940 E. NorthwestHighway, Prospect, IL. 60056 USA.

NOTE: It’s quiteexpensivefornon-members.

Test methodswhich would apply to glovesare:

ASTM F 24-00: "StandardMethodfor MeasuringandCounting ParticulateContaminationonSurfaces".

ASTM F 1731-01: "StandardTestMethodfor GravirnetricDetermination of Non-volatileResiduesfrom CleanroomGloves"

ASTM D 6124-01: "PowderContentof Powder-FreeGloves" -

Thetesting requirementsshouldbe part of the purchasingagreement betweenthe manufacturerandthecustomer.

S..

I am a toxicologist in a contract laboratory. Traditionally,for cytotoxicity assaysas required by ISOIUSP biocompatibility testing, we havebeenusing a latex glove formulationas a positive control. Ourcurrent lot of gloves was validatedseveralyearsago andwearerunning low on the remaining supply. I haveorderedseveral different latex glovesfromdifferent manufacturers torevalidate but cannot find anythat will give a positive response.

I was wondering If therewasany way we could purchasealow-grade latex formulationthat would not meet the standards required for human-useproducts. I needaproduct thatwill consistently yield failinggrade 3 or higher results inagar overlay cytotoxicity testing. Any suggestions,please?

Annetta HerringtonSTS duoTEK, Inc.

rfhis is aninterestingquestion.It seemsthat general glove

quality hasimproved andit is nolonger common for NR latexglovesto causepositive cytotoxicreactions.There is no good reason why that did not happenatleast 15 yearsago.

I made some film for Ms.

Harry F. Bader

Harry F. Bader,Vice-President,LatexServices,AkronRubberDevelopmentLaboratory, Akron,USA, and a worldauthority on latex,answersquestionsand doubtsofreaderson latexand latex products.

Send your questions to:

‘The Latex Doctor’Rubber Asia,Dhanam House,Cochin - 682 020,Kerala, IndiaFax: 94-484-31 7872

RubberAsla * November . December 2002 81

82

Herrington from a popularcommercialpre-vulcanizedNR latexcompound. I did no leaching orwashing. I followed a very simpieprocess.* Coagulantdip, dry 20 minutes

at 50°C.

* Latexclip, dry 1 ½ hoursat50°C.

* Powderwith CaCO3,strip

Samples were sent to Ms.Herrington,shereported"nopositive reaction". Which meansacceleratorresiduesarepresentinsufficiently to causea positivereaction.

I later made a post-vulcanization compound with moderately high carbamateandthiazoleacceleratorcontent. Thiswasprocessedwithout leachingorwashingand did provide thedesired "positive control" Ms.Herrington neededfor her testing.

S..

We make surgeon’s glovespowdered with coagulantdipping process. Pleasesuggestsome cleaning solutions foronline ceramicmould cleaning,after stripping? We now useImportedceramicmould cleanerCMC3 & CMC2 from Malaysia. Now, our dealer is unableto supply thesameAwaiting foryour valuablereply.

K. Muralidharan,for TTK HealthcareLtd.

I f your coagulantcontainscalcium carbonateas thepowder

for easeof stripping and as thebasicpowderfor theglove, yourformer cleanershouldbe anacid,So it will reactwith theCaCO3.

If theCMC3 andCMCZ materials worked well for you, whynot sendsamplesof themto a laboratory for analysis?

That would provide a formulafor you to make up your ownequivalent of the CMC3 andCMC2. If you cannotlocate alocal lab to do that work, contactharryb@ardl.com.

An alternative is a dippingformercleanerfrom OakiteProducts, Inc. ,50 Valley Road,BerkeleyIlls., NewJersey07922-2712; Telephone908-464-6900.

Fax:908-464-4658; Website:www.oakite.com

...

We are planning to put up asurgical gloves plant in India.So we are in searchof machinery manufacturers. Since, youare the expert, please suggestwhich type from which manufactureris cheapandbestto suitIndian conditions. If you haveany Information, pleasesenddetails through e-mail,

Addressnot mentioned

A CC Automation is the logical choice. Their equip

ment can be tailored to your individual needs.They canprovideengineereddrawings only, orthey can provide a full turnkeyplant. It is your decision.

ACC Automation is a frequentadvertiserin RubberAsia. Contact char1tonaccautomation.com or write to 475, WolfLedgesParkway, P0 Box 568,Akron, Ohio 44309 USA. Telephone: 330-762-9188or fax:330-762-1113.

S..

A questioncameup at ourLatexSafetyMeetingaboutwhether items in the patients’ roomswerelatex-free.Therewasconcern about the reusahlebloodpressurecuffs andthe black-extension blood pressuretubing.I know thereplacementitemsInour warehouseare latex-free,but I am not surewhat the olditems in the room are. Most ofthese older items are notmarked. Is there any simplemethod to determineif an itemcontainslatex - a chemicaltestof sometype that could be performed in a patient’s room?

CharlesPlatt,Medical Centerof Central

Georgia.

hereis no simpletestfor natural rubber latex protein con

tent. The testsin commonusearedestructive for the item beingtested.

In today’slitigious climate,I canunderstandtheconcernaboutlatexallergylawsuits.For peaceof mind,I suggestyou replacethe itemsaboutwhichyou haveconcerns.

RubberAsia I November December 2002