Technical Facility Management. M+W Process Industries GmbH. Consulting Planning Property Management Maintenance Recertification Recalibration

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Hillary Watson
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1 Pharmaceutical Industry Biotechnology Industry Chemical and Fine Chemical Industry Medical Devices Industry Consumer and Beauty Care Industry Food Industry Technical Facility Management M+W Process Industries GmbH Consulting Planning Property Management Maintenance Recertification Recalibration

2 Technical Facility Management Technical Facility Management Validation Construction Engineering Consulting Technical Facility Management for GMP Regulated Industry M+W Process Industries GmbH offers you complete engineering and construction solutions for all project phases in the process technology, mechanical and GMP regulated industries in one stop. Our services in the area of technical facility management extend to the following industries: Pharmaceutical industry Biotechnology industry Chemical and fine-chemical industry Medical devices industry Consumer and beauty care industry Food industry As an overall designer and plant manufacturer, M+W Process Industries GmbH offers comprehensive solutions in the area of technical facility management for GMP/ FDA compliant, safe and economic opera-tion of various production facilities. We analyze and evaluate your needs, develop operation and optimization concepts and then implement them. As a plant designer and manufacturer, we are familiar with various needs and product processes and develop variants for individual operators.

3 Operator Advantage Optimization and Reorganization The largest potential in technical facility management lies in cost saving and time optimization through process integration and the minimization of interfaces. This optimization requires a corresponding knowhow which is provided by the experienced service provider M+W Process Industries. The following decisive advantages are provided to operators within the scope of result oriented planning and the services of M+W Process Industries: A responsible contact partner for all services Contractual processing of all services via an individual service contract Guaranteed availability and retention of the value of your systems (operating security) Cost transparency and budget security for the operation of technical systems and process equipment Guaranteed quality of service via trained service personnel who are familiar with the current GMP and FDA regulations A regulated malfunction strategy and short reaction times for the remedying of malfunctions Transparent and complete GMP compliant documentation of all services and system conditions

4 Tasks and Objectives Economic and GMP Compliant Operation The objective of technical facility management is the planning and realization of all secondary processes necessary for production. Technical facility management is charged with the following tasks: Guaranteeing operational security and efficiency Providing the highest degree of availability for all technical facilities and systems Providing GMP compliant and inspection ready documentation Minimizing and/or optimizing downtime during maintenance, recertification/revalidation and recalibration Decisive processes for the goal oriented remedying of malfunctions "EU Guidelines for Good Manufacturing Practices" Premises and Equipment Principle Premises and equipment must be located, designed, constructed, adapted and maintained to suit the operations to be carried out. Their layout and design must aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build up of dust or dirt and, in general, any adverse effect on the quality of products. Premises/General Premises should be carefully maintained, ensuring that repair and maintenance operations do not present any hazard to the quality of products. They should be cleaned and, where applicable, disinfected according to detailed written procedures. Equipment 3.35 Repair and maintenance operations should not present any hazard to the quality of the products. 4 Building and Facilities 4.20 All utilities that could impact on product quality (e.g. steam, gases, compressed air and heating, ventilation and air conditioning) should be qualified and appropriately monitored and action should be taken when limits are exceeded. Drawings for these utility systems should be available. 5 Process Equipment Equipment Maintenance and Cleaning (5.20) Schedules and procedures (including assignment of responsibility) should be established for the preventative maintenance of equipment. 4.7 Sanitation and Maintenance 4.70 Buildings used in the manufacture of intermediates and APIs should be properly maintained and repaired and kept in a clean condition.

5 Our Focus GMP Regulated Devices and Systems Laboratory Equipment M+W Process Industries Clean Utility Systems Technical Facility Management Building Services 21 CFR 211 Part D Equipment Cleaning and Maintenance of Equipment (a) Equipment and devices should be cleaned, maintained and kept clean at reasonable intervals...

6 Our Process The Integrated Approach M+W Process Industries GmbH offers all services from the planning of technical facility management to the operation of all facilities and systems. The use of synergy between the areas of maintenance, recertification and recalibration, is a top priority at the planning stage. M+W Process Industries many years of experience as well as numerous references for the design and operation of pharmaceutical production facilities confirms our approach. Consulting Engineering Service Organization Building technology Clean rooms Production Operations flow GMP requirements Regulation Maintenance strategies Operating services EDV systems CAFM/DMS* SOP creation Property management Maintenance Malfunction management Recertification Recalibration System optimization GMP documentation Specific operator requirements profile * CAFM: computer added facility management * DMS: document management system We provide all services with our own GMP trained personnel, audited partners and measuring devices that are always calibrated.

7 Our Services M+W Process Industries Technical Facility Management We guarantee GMP compliant and inspection ready service for your technical facilities and process equipment. Consulting and Planning Determination of planning context, operator concepts, maintenance planning, creation of SOPs. Property Management Coordination of all services, operation, maintenance, malfunction management, recertification, recalibration, GMP documentation. Maintenance Inspection, maintenance, repair and optimization of technical building systems and process facilities as per DIN 31051, VDMA etc. Process Support Supply and disposal of media / material for production processes, operation of technical facilities and machines. Malfunction Management Definition of decisive procedures for the remedying of malfunctions, operation of a support center (24 h), coordination and implementation of measures to remedy malfunctions, analysis and reporting. Recertification and Recalibration Implementation of recertification and recalibration processes as per ISO 14664, VDI 2083, IES RP-C C006.2, DKD, PTB etc. Intervalle TGA systems Process equipment Monitoring systems Operation regularlly regularly (service/monitoring) regularly regularly Maintenance (inspection, maintenance, repair) 6 months to 1 year 6 months to 1 year 6 months to 1 year Requalification 6 months to 2 years 6 months to 1 year Recalibration 1 year 1 year 6 months to 1 year Service continuously continuously continuously

8 TFM.en/ M+W Process Industries GmbH A Company of the M+W Group (Headquarters) Lotterbergstr Stuttgart, Germany Phone: Fax: info.pi@mwgroup.net Business Unit Pharma, Lab, Cleanroom Branch Office Nuremberg Phone: nuremberg.pi@mwgroup.net Regional Office Berlin Phone: berlin.pi@mwgroup.net Regional Office Rhein-Main-Neckar Phone: rmn.pi@mwgroup.net Business Unit Bioprocess Facilities Headquarters Stuttgart Phone: info.pi@mwgroup.net Regional Office Biberach Phone: biberach.pi@mwgroup.net Regional Office Marburg Phone: marburg.pi@mwgroup.net Regional Office Penzberg Phone: penzberg.pi@mwgroup.net Business Unit Chemical and Fine Chemical Facilities Office Leuna Phone: leuna.pi@mwgroup.net Office Ludwigshafen Phone: ludwigshafen.pi@mwgroup.net Regional Office Burghausen Phone: burghausen.pi@mwgroup.net Regional Office Frankfurt a. M. Phone: frankfurt.pi@mwgroup.net Regional Office Hamburg Phone: hamburg.pi@mwgroup.net Regional Office Schwarzheide Phone: schwarzheide.pi@mwgroup.net Regional Office NRW / Leverkusen M+W Inducon GmbH Phone: inducon@mwgroup.net Locations Austria Branch Office Vienna Phone: at.pi@mwgroup.net Regional Office Kufstein Phone: Regional Office Linz Phone: Locations South East Europe Please contact Branche Office Vienna, Austria Locations Switzerland Branch Office Basel Phone: ch.pi@mwgroup.net Regional Office Zurich Phone: Locations Scandinavia Please contact Regional Office Zurich, Switzerland Locations Belgium Branch Office Melsele Phone: benelux.pi@mwgroup.net Regional Office Wavre Phone: Location The Netherlands Branch Office Helmond Phone: benelux.pi@mwgroup.net Locations Poland Branch Office Gdansk Phone: pl.pi@mwgroup.net Regional Office Warsaw Phone: Regional Office Wroclaw Phone: Location Russia Branch Office Moscow Phone: ru.pi@mwgroup.net Location Brazil Branch Office São Paulo Phone: info.brazil@mwgroup.net

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