INNOVA® P-SeriesPharma cGMP Compliant Washers

Founded in 1978, BHT is one of themarket leaders for the design of innovative washer-disinfectors forhospitals and laboratory. The range of products extends from small under-counter washer-disinfectors,to medium and large sized singlecabin machines to large-scale multi-chamber tunnel washer-disinfectorsused in hospitals.

The BHT Pharma Solutions divisionwas founded in 2002 with a new team of specialized personnel withover 30 years experience in deliveringsolutions to the pharmaceutical industry. Within one year BHT PharmaSolutions has designed and developeda complete range of high quality washing and drying machines specifically for the pharmaceuticalindustry. The new line-up of machinesincludes quality and innovationswhich have proven to be the rightchoice for the pharmaceutical industry.These machines are designed to beused in production, research and laboratories.

BHT is certified to DIN EN ISO 9001.

BHT – experts for innovativecleaning and drying techniques for the pharma-ceutical industry

BHT – Benefit from 30 years of BHT-Experience in the Pharmaceutical Industry

INNOVA®

BHT washers are manufactured with the highest workmanship and quality,they are designed from the start to be validated. All of our washers include acomplete validation package conform to cGMP, GAMP and FDA standards.

All of our washers will adapt easily toyour existing infrastructure. BHT makes a wide range of load carriers for productioncomponents, glassware, hoses, etc. and iswell known for our custom load carriersto meet special requirements.

Our innovations create the futureWe create new products, new servicesand more benefit for our customers.We enjoy experimenting and encourage creative thinking. With creativity, lateralthinking and teamwork, we generate thebreeding ground in which new ideas andconcepts can grow fast and easily.

Keeping an open mind and learning allthe time, we are continuously improvingWe compare ourselves to the best in thefield. Each one of us is continuously learning. We look for and give feedbackand we learn from it. Faster than otherswe recognize new opportunities andadopt solutions, organization and behavior accordingly. We cooperate with an international network of independentpartners and learn from them as well.

The P-Series

A b o u t B H T P h a r m a S o l u t i o n s

The Best is our StandardA p p l i c a t i o n s a n d o u r c G M P - S t a n d a r d s

Sterile and non-sterile ApplicationsProduction components (pipes, pumps,clamps, gaskets, etc.) Glassware (flasks, beakers, bottles, etc.)Hoses (various lengths, materials andclamps)TraysIBCs (containers, drums, buckets, etc.)

Fully cGMP compliant washing processFinal Rinse either direct or re-circulatedConductivity control for final rinseHEPA filtered hot-air drying

Fully cGMP compliant built standardsWash chamber – either hand-polishedor electro-polished All wetted surfaces slope to drainAll chamber corners widely radiussedto prevent contamination

Residual between cycles 0.2 %Chambers with Ra 0.2µm [ 8 Ra]Gap Free 100 %Glass Doors1D-RuleWFI Water Consumption 20l/minDynamic Life-Cycle Model

-WeldingOpen Standards

BHT Pharma Solutions – Setting new cGMP Standards

IBC loaded into washer Wash program being started Wash program running

Only FDA approved materialsTri-clamp or flange-connection for pipe-workPharmaceutical valvesP&ID, FDS for Design Qualification and approvalCompliant with Standards and Regulations including: DIN, CEN,VDE, IEC, cGMP, GAMP, FDA

P6P12

P9

Flexible

BHT Pharma Solutions offers a completerange of services:

Planning, Development, Installation,Commissioning of washers for thePharmaceutical IndustryOptimized Processes & comprehensiveSecurity LevelsCustom built from our modular Construction SystemDelivered to Specification, on TimeAll Procedures qualified, validated anddocumented

consulting + r&d + design +

manufacture + sales + service

= one single source

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Efficient

Behind the Success there is a SystemP e r f o r m a n c e f e a t u r e s a n d c o n s t r u c t i o n

Performance with Optimal ControlNewly designed efficient and powerful steam heat exchanger for improved cleaning, completelyrounded and with tapered flangeRacks connected by a simple andefficient clutch system at the docking point on the machine’s water supplyHigh power drying system fed directly after HEPA Filter into chamberMonitoring of complete system for the control and validation ofthe wash cycleFlexible control software which allows for a wide variety of washing cycles (i.e. direct rinse,pulsing, re-circulated rinse,pre-heating of water, etc.)

Reliable – High Quality ComponentsDoor(s) are 100 % in tempered safety glassUse of high quality componentssuch as from Hilge, Wika, Siemens,Endress+Hauser, Allen BradleyTouch screen user interface offerssimple visual and prompted operators controlsEasy positioning and fixing of loadcarrier with ergonomically designedloading level

Compliant – Fully cGMP CompliantStainless steel surface finish washchamber with round edge design.Consequent coving – radius cornersr =20mm [0.79"] – of wash cabin,wash tank and intrusions into the cabin

Consequent grinding & polishingof internal surfaces & welds,Ra 0.8µm [ Ra 30]All piping and valves on one side,Piping with slope ≥3 % for self drainingLatest GAMP software design standards for effective validation in pharmaceutical facilities

Flexible – Designed for effective in-stallation in pharmaceutical facilities:

Wide range of chamber sizesDoor(s) are available in differentversions (Automatic, Sliding upwards,Sliding to right or left side, or Manual)Pass-through or single ended operation. Gas-tight for differentialpressures between rooms.Service access from dirty side only and easy access to allinstrumentation and devices from single technical areaDepending on application, differenttypes of stainless steel surfaces –matt and polishedWash racks tailored to your specificloads with integrated spray nozzlesCustomer specific CommunicationInterfaces (i.e. Network, SCADA)

Dead-leg- & crevice free machineand load carriersComplete documentation with DQ Package, FDS Package, Weldinghistory, Electrical documentationacc. to EN/ISO 60204, FAT/IQ/OQProtocolsFDA approved materials with 3.1BCertificates

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Good Results by Pushing a ButtonValidation and Documentation

For every kind of LoadCustomized Wash Racks

Put it into our RacksBHT designs customized wash rackswhich are engineered to your individualneeds and specifications. The racks aremanufactured in 316L and come completewith certificates and documentation.

Reliable

ValidationThe self diagnosing PLC (either Siemensor Allen Bradley) with touch panel together with the components used inthe machine will guarantee a qualifiedtreatment of the wash loads.

A report is automatically generated atthe end of each cycle and can either beprinted or sent to a network.

DocumentationPrior to start of manufacturing, BHT supplies a complete DQ documentationpackage for review and approval. FAT protocols as well as an IQ/OQ documentpackage are available for a complete andthorough validation.

Depending on the needs of the projectdifferent levels of documentation areoffered. This allows you to select the bestdocumentation suited for your project.

Everything under ControlOur pharma washers are as easy to useas a dishwasher at home. Using thetouch screen display, the user operatesthe machine simply by selecting the stored program and pressing start.Special tools are included to develop and optimize wash process. A complete display of machine parameters and status assist during maintenance andservice periods.

1. PLANNING

Validation Plan

2. DEFINITION

User Requirements Specification

3A. DESIGN

Functional Specification

3B. DESIGN

Hardware Design Specification

3C. DESIGN

Software Design Specification

4. REVIEW & APPROVAL

Software Module Design Specification

6. SOFTWARE

MODULE TESTING

5. SYSTEM BUILD & CONTROL SYSTEM

SOFTWARE PROGRAMMING

REGULAR REVIEWS & TESTING

9. + 10. SYSTEM

ACCEPTANCE TESTING

Installation QualificationOperational Qualification

8. HARDWARE

ACCEPTANCE

Hardware Factory Acceptance Test

7. SOFTWARE

INTEGRATION TESTING

Software Factory Acceptance Test

The Project Lifecycle

Compliant

Different Sizes for Different Applications

BHT Hygienetechnik GmbHPharma SolutionsHeisenbergstraße 8A84544 Aschau am Inn / GermanyTel. +49 (0)8638/98268-100

Fax +49 (0)8638/98268-111

Internet: www.bht.deE-Mail: pharma@bht.de

A c c e s s o r i e s a n d t e c h n i c a l d a t a

INNOVA® P6 INNOVA® P9 INNOVA® P12

Dimensions: 1700 x 1100 x 2700 [3000] mm 2000 x 1400 x 2700 [3000] mm According to available space,67 x 43 x 106 [118] inches 79 x 55 x 106 [118] inches also available as floor loading

version.

Optimal useable: 640 x 640 x 740 [940] mm 940 x 940 x 740 [940] mm Depending on size of goodsWash area 25 x 25 x 29 [37] inches 37 x 37 x 29 [37] inches to clean

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Certified by DQS according toDIN EN ISO 9001: 2000

DIN EN 13485: 2003Reg. No. 019906-01

Depending on your application, we offer different sizes of wash chambers to meet yourneeds. All are built with the same high cGMP standard.