Temperature mappingand autoclavevalidation

Who are we?We are Thermal Compliance, specialists in temperaturemapping and autoclave validation.Founded in 2007, we are anindependent validation serviceprovider to the pharmaceutical,biotechnology and healthcaresectors internationally.We provide validation, calibration,equipment hire and temperaturemapping services.Our autoclave validation servicesinclude: EN285 testing HTM2010 testing installation qualification operational qualification cycle development performance qualification troubleshooting.2Our temperature mapping andvalidation services are used forequipment and environments suchas: fridgesfreezersincubatorsovenswarehousesstorage roomshumidity cabinetsstability rooms.We have a wide range of equipmentavailable to hire including KayeValidator 2000s and thermal testingequipment.We also offer products includingthe 3M Electronic TestSystem, biological indicators,thermocouples, and autoclave tape.

Temperature mappingWe provide temperature mapping, thermal validationand humidity mapping services for temperature criticalequipment.We perform testing over a range of-196 to 400 C, and 0 to 95% RH.We use GE Kaye Validator 2000and wireless data loggers capableof logging every second to givea detailed analysis of yourtemperature critical environment,performing work to either ourStandard Operating Procedures(SOPs) and protocols, or your owndocumentation.We also offer onsite calibrationservices for temperature andpressure.We perform temperature mappingon various healthcare, process,laboratory and storage equipment,including: Laboratory: incubators;ovens; humiditychambers; autoclaves Process: freezedriers; steam-inplace; depyrogenationtunnels; autoclaves Product storage: fridges; freezers;cold stores; warehouses; liquidnitrogen tanks; stability roomsOur knowledge of US and EUindustry guidelines – such as theOrange guide, ICH guidelines andASTM E2500 – is key to providingyou with a clear and compliantvalidation approach.3

Autoclave validationAt Thermal Compliance we specialise in autoclavevalidation to UK, EU and international standards for thepharmaceutical, biotechnology and healthcare sectors.Our experience and expertise willgive you a clear, compliant andtransparent autoclave validationpackage. Awareness of current EUand US regulatory requirements isessential.We can qualify your autoclave toEN 285:2006, EN 17665 and PDATechnical Report 01 to meet MHRA,IMB and FDA expectations.Validation Services: Installation/Operation Qualification(IQ, OQ) Cycle/Load Development (CD) Performance Qualification (PQ)and Re-Qualification (RQ) EN 285:2006 testing Pressure and temperature airdetector setup Audits and consultancy support Steam quality testing HTM 01-05 testing HTM 2010 testing.4

Equipment hireOur GE Kaye Validator thermal validation systems areavailable for hire with current calibration certificates.We also offer thermal baths from-80 C to 400 C and IRTD-400s.There is no minimum hire period;all of our equipment is deliveredin protective cases with currentcalibration certificates; additionalvalidation accessories are alsoavailable.Items for hire include: Kaye Validator 2000 (versions 3.6,3.5, 3.1, 2x) including 3 SensorInput Modules (SIMS), powerlead, serial cable, USB cable, andcalibration certificatestemperature range -196 C to400 C Kaye HTR-400, temperature range50 C to 400 C, accuracy 0.2 Cto 0.4 C.Other equipment that we haveavailable to hire includes: entryglands, pressure transmittersand temperature and humiditydataloggers. Kaye LTR-140 (-40), temperaturerange -40 C to 140 C Kaye LTR-140 (-25), temperaturerange -25 C to 140 C Kaye M2801 / IRTD-400,5

ProductsAt Thermal Compliance, our approach is to identify andembrace forward-thinking solutions.We find innovative solutions to improve performance through timesaving, andby increasing quality of data and ease of use. Our products include:3M Electronic TestSystems (ETS)We distribute the 3M ElectronicTest System (ETS) a paper freeelectronic Bowie & Dick Test.We provide validation support toassist your move to a paperlesssystem.ETS provides comprehensive,objective, independent informationabout the criticalvariables of thesteam sterilizationprocess.6

Biological indicatorsAutoclave tape 3M Attest BiologicalIndicators for Ethylene Oxide (EtO)Sterilization. 3M Comply Steam IndicatorTape. Individually wrapped. 3M Attest Rapid ReadoutBiological Indicator for Steam. 3M Comply Ethylene OxideIndicator Tape. Individuallywrapped. 3M Attest BiologicalIndicators for SteamSterilization.Standard Towel PacksBespoke Thermocouples For use in HTM2010 & EN285Testing. Bespoke for use with KayeValidator Class 1 (Premium) Type T cable Colour coded to IEC 584-3 FEP Encapsulation & Welded Tips Numbered.7

Contact us:Thermal Compliance LimitedThe GranaryStreatlam Home FarmCounty DurhamDL12 8TZUK Call 44 (0)1833 908 002 Email [email protected] can also find us Thermal Compliance Limited 2013.Thermal Compliance Limited is a company registered in England.Registered number: 6155116.Registered address: The Granary, Streatlam Home Farm,Barnard Castle, County Durham, DL12 8TZ.VAT Number: GB915 787780000

We use GE Kaye Validator 2000 and wireless data loggers capable of logging every second to give a detailed analysis of your temperature critical environment, performing work to either our Standard Operating Procedures (SOPs) and protocols, or your own documentation. We also offer