BT Cleanroom Engineering - HVAC solutions for controlled environments

ENGINEERING FOR CLEANROOMS AND CONTROLLED ENVIRONMENTS

B T C l ea n ro o m E n g i n e e r i n g ® - a b ra n d b y BA R T S p. z o. o.

BT Cleanroom Engineering® a brand by BA R T S p. z o. o.

ENGINEERING FOR CLEANROOMS AND CONTROLLED ENVIRONMENTS

Table of contents

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BART Sp. z o.o.: Solutions for clean air

2

BT Cleanroom Engineering®: Solutions for cleanrooms

4

Scope of services

6

Scope of solutions

14

Experience of BART Sp. z o.o. in selected industrial sectors

28

Reference projects in the field of cleanroom technology

30

1

BA R T S p. z o. o.

2

Clean Air Engineering BTIS Group | Together for a Clean Tomorrow

BART Sp. z o.o.: Clean Air Engineering

BART Sp. z o. o. has been operating in the industrial investment market for over 20 years.

It offers investors “design and build” services, specializing in sanitary installations, particularly process dust removal systems, ventilation, air conditioning, and refrigeration systems for manufacturing companies from a wide range of industries.

It implements " Clean Air Engineering" solutions that support environmental protection and create a clean, healthy, and friendly microclimate in the workplace. To this end, it uses its own technologies and technologies from valued partners, both European and global.

The range of engineering services provided includes design with the selection of technologies and

equipment,

delivery

assembly

on

the

construction

site,

installation

of

industrial

installations, their commissioning and validation, as well as extensive construction services.

In addition to construction, the company provides service as part of the warranty and post-warranty service of installed filter ventilation systems and advises on maintenance.

For many years, Bart has been comprehensively implementing projects in the field of cleanrooms and related controlled environments in terms of the concentration of dust in the air and microbiological cleanliness.

BART Sp. z o.o. is a member of BTIS Group - Together for a Clean Tomorrow.

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BT Cleanroom Engineering® ENGINEERING FOR CLEANROOMS AND CONTROLLED ENVIRONMENTS

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BT Cleanroom Engineering® 4

A b ra n d b y BA R T S p. z o. o.

BT Cleanroom Engineering®: Engineering for Cleanrooms and Controlled Environments

BT Cleanroom Engineering®, a brand by BART Sp. z o. o., offers solutions for clean rooms and controlled environments. The brand’ s offer is addressed to laboratories and industries where the production of elements and components sensitive to the quality of the surrounding air takes place, whose final particulate and microbiological cleanliness is a condition of quality and admission to trade. It includes the necessary technologies that allow for the protection of products and processes against damage caused by contaminated air, the protection of the health of people exposed to pollution, and the protection of the external environment against the emission of harmful factors generated during performed activities.

The key solutions of the BT Cleanroom Engineering® brand are based on precise ventilation and

air

conditioning

systems,

technological

and

workstation

exhaust

systems,

and

accompanying installations. They support the control of the concentration of dust particles in the air and the regulation and control of other essential air parameters. They also include devices and systems for separating and enclosing clean areas, designed to minimize the introduction, generation, and deposition of dust particles inside the rooms.

The company meets the high requirements of the electronic, optical, semiconductor production, chemical,

biotechnological,

high-tech,

scientific,

food

and

beverage

production,

and

pharmaceutical industries, especially the drug production sector.

Collaboration with BART Sp. z o. o. means working with experienced specialists in the field of cleanroom technology. w w w. b t c l e a n r o o m . p l

BT Cleanroom Engineering® ENGINEERING FOR CLEANROOMS AND CONTROLLED ENVIRONMENTS

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SCOPE OF SERVICES Clean Air & CleanRoom Engineering

Scope of services

Consulting, concept development, and design, selection of equipment and materials Comprehensive installation, delivery logistics, start-up, and regulation Qualification and validation. Measurements and research. Service.

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SCOPE OF SERVICES Clean Air & CleanRoom Engineering

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SCOPE OF SERVICES Clean Air & CleanRoom Engineering

Consulting, concept development, and design, selection of equipment and materials

BART Sp. z o. o. has offices in four of the most important regions in Poland: Warsaw, Wrocław, Gdańsk, and Sosnowiec. Based on experience, the technical and design department develops executive projects of various industrial installations along with accompanying construction projects.

An experienced team of engineers dedicated to BT Cleanroom Engineering® solutions develops a tailored solution concept, selects appropriate technologies and equipment. A particular challenge is the development of concepts for industrial, production, and laboratory rooms for later validation according to GMP and ISO principles for cleanrooms, as well as those appropriate to ATEX directive regulations.

When providing comprehensive cleanroom investment services, Bart specialists help develop user requirement specifications (URS) to determine the critical requirements of the built clean rooms. This specification includes, among other things, general requirements for the object’ s architecture, requirements for the HVAC system, BMS, RMS systems, and rooms and technical infrastructure of the object; detailed requirements related to critical technological processes, the scope of qualification and validation activities.

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SCOPE OF SERVICES Consulting, concept development and design, selection of equipment

Consulting and advisory services: •

Feasibility analysis

•

Profitability and efficiency diagnostics

•

GMP requirements implementation

•

RA and URS documentation development

•

Equipment and material selection

Concept and design: •

Conceptual projects

•

Construction documentation for building permits

•

Executive projects

•

Cleanroom technological projects

Cleanroom enclosure system: •

Structural design for enclosure

•

Enclosure design for walls, ceilings, and floors

•

Equipment and installation foundation design

Installation engineering projects:

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•

Mechanical ventilation and air conditioning HVAC

•

Telecommunications and fire protection installations

•

Electrical installations, lighting, KD, locks

•

BMS, RMS automation

•

Technical gases

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SCOPE OF SERVICES Clean Air & CleanRoom Engineering

Comprehensive installation, delivery logistics, start-up, and regulation Cleanroom projects require comprehensive services that cover all stages of investment. After designing and developing the concept, the company offers installation of cleanroom enclosures and technical installations, including precise ventilation and air conditioning systems, technological and workstation exhaust systems, central vacuum installations, and hygienic enclosures with accompanying installations necessary to start planned production processes.

The company has its own qualified installation teams and ensures constant supervision by engineers with construction qualifications. Bart guarantees high quality of services provided and operates in accordance with the procedures and highest standards of the certified management system according to the PN-EN ISO 9001:2015 standard.

During the implementation of the investment, the company ensures the completion of orders for equipment and materials, as well as optimization of delivery logistics. Bart specialists verify the correct functioning of installations and controlled areas during start-up. They carry out precise regulation of air parameters, such as temperature, humidity. The performance of air supply and exhaust vents, pressure cascades between rooms, and technological media parameters, such as purified water or compressed air, are also subject to regulation.

The company also offers installation of cleanroom enclosures, HVAC, electrical, automation, and accompanying installations, as well as earthworks, foundation, and construction work upon request. The company prepares comprehensive post-execution documentation.

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SCOPE OF SERVICES Comprehensive installation, logistics, s t a r t - u p, a n d r e g u l a t i o n s .

•

Installation work of cleanroom enclosures

•

Installation of HVAC, electrical, automation, and accompanying installations

•

Continuous supervision by engineers with construction qualifications

•

Execution of preliminary performance regulation of installations and measurement of work parameters

•

Preparation of comprehensive post-execution documentation

•

Upon request, earthworks, foundation, and construction work

•

Completion of orders and delivery logistics on the construction site

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SCOPE OF SERVICES Clean Air & CleanRoom Engineering

Qualification and validation. Measurements and research. Service.

The User Requirement Specification (URS) document is the basis for conducting validation tests and assessing the quality of clean rooms from the point of view of GMP requirements.

As part of comprehensive project management, Bart offers clients measurement of air parameters in clean rooms, conducting DQ project qualification, IQ installation qualification, OQ operational qualification, and support for PQ process qualification - at every required stage. The company also proposes to conduct comprehensive validation work.

After successful validation work, the company’ s specialists proceed to train personnel in the operation and maintenance of installed equipment and systems.

The company also offers periodic maintenance inspections. It services installed systems and equipment.

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SCOPE OF SERVICES Qualification and validation.

Measurements. Service.

Qualifications at every stage of project implementation: •

Project Qualification (DQ)

•

Installation Qualification (IQ)

•

Operational Qualification (OQ).

•

Support in (PQ) Process Qualification, Support in validation of computerized systems Measurements and research, including:

•

D e t e r m i n a t i o n o f t h e d u s t c l e a n l i n e s s c l a s s i n t h e ro o m

•

M e a s u re m e n t s o f t h e a m o u n t o f s o l i d pa r t i c l e s i n t h e a i r

•

Examination of possible contamination leaks

•

E x a m i n a t i o n o f t h e i n t e g r i t y o f H E PA a n d U L PA f i l t e r s

•

Examination of the uniformity of laminar air supply and air velocity

•

M e a s u re m e n t o f a i r f l o w ra t e

•

M e a s u re m e n t o f ro o m re g e n e ra t i o n t i m e ( R e c o v e r y t e s t )

•

V i s u a l i z a t i o n o f a i r f l o w M e a s u re m e n t s o f t e m p e ra t u re a n d h u m i d i t y, a s w e l l a s p re s s u re d i ff e re n c e s b e t w e e n ro o m s

•

M e a s u re m e n t o f l i g h t i n t e n s i t y

•

M e a s u re m e n t s o f t h e a va i l a b l e p re s s u re o f t h e c e n t ra l u n i t

•

C a l i b ra t i o n o f m e a s u r i n g t ra c k s

Training in the operation and maintenance of installations upon transfer to use Equipment and installation service necessary to maintain warranty conditions and post-warranty service.

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

Scope of solutions

HVAC systems for precise ventilation and air conditioning.

Cleanroom enclosure systems.

Industrial automation, RMS and BMS systems, electrical installations.

Technological exhaust systems for dust and gases. Explosion-proof dust removal systems.

Elimination of volatile organic compounds.

Central vacuum and transport systems. Mobile vacuum cleaners.

Technological and peripheral installations for cleanroom zones.

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

Precision ventilation and air conditioning systems HVAC

Ventilation installations dedicated to laboratories, zones, and cleanroom-type rooms with high hygienic requirements enable the achievement and maintenance of very precise air parameters, such as temperature, relative humidity, and pressure in rooms using appropriate ventilation, cooling, heating, drying, and humidifying devices. These mechanical ventilation installations are

supported

by

object-based

installations,

water

installations,

technological

heat

installations, and water and sewage installations. They make up a comprehensive HVAC and sanitary installation system.

Tasks for ventilation and air conditioning installations for precise control of air parameters are included in project guidelines for investments regarding the dust and microbiological cleanliness class of air in a given room, classified according to PN EN ISO 14644-1 or Good Manufacturing Practice (GMP).

The proper selection of ventilation technologies prevents the flow of dust, gases, and vapors between neighboring cleanroom zones, thus allowing for control of the migration of pollutants and protecting against cross-contamination in critical process zones. Ventilation and air conditioning installations for precise control of air parameters help maintain appropriate conditions for the production, storage, processing, and transport of raw materials, products, or materials.

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SCOPE OF SOLUTIONS Precision ventilation a n d a i r c o n d i t i o n i n g s y s t e m s H VA C

•

Object ventilation mechanical installations

•

Ventilation and air conditioning installations for precise control of air parameters

•

Dehumidification and humidification of air

•

Control of pollution migration

•

Pressure cascade

•

Chilled water installations

•

Technological heat installations

•

Water and sewage installations with water and sewage treatment plant and central heating

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

Cleanroom enclosure systems Bart Sp. z o. o. also offers comprehensive services for the proper separation of cleanrooms in accordance with technology requirements. When designing and installing horizontal and vertical cleanroom and controlled area enclosures, they use systemic solutions from Polish and recognized manufacturers. Among them are systemic elements for wall and ceiling enclosures, carpentry elements of doors and windows, lighting modules dedicated to clean rooms with a class from ISO 3 to ISO 8 according to the PN EN 14644-1 standard, observed in areas of pharmaceutical, food, dermocosmetics, or electronic production.

The

appropriate

configuration

of

personal

and

goods

sluices,

pass-through

windows,

pass-through cabinets, isolators, and other enclosure devices and elements ensures proper flow of raw materials and products, maintains dust and microbiological cleanliness, and protects against cross-contamination. The selection of appropriate materials from which the enclosure elements and equipment are made is also essential to ensure and maintain high hygiene standards in the rooms.

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SCOPE OF SOLUTIONS Wall and ceiling cladding systems.

Modular systems for cleanrooms.

•

Complete wall and ceiling cladding systems for cleanrooms

•

Ceiling panels

•

Joinery: hinged and sliding doors

•

Dust-free industrial floors, poured or in the form of ready-made carpets

•

Airlocks and pass-through windows: personal airlocks, material airlocks, air showers

•

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Laminar chambers and isolators

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

Industrial automation, RMS and BMS systems, electrical installations

In areas of pharmaceutical, medical, biotechnological production, or laboratories requiring constant control of the environment of production and storage, as well as ensuring comfort and safety for employees, low-voltage control systems and automation installations are used.

Industrial control systems for individual ICS parameters and entire RMS rooms provide continuous monitoring of parameters and internal event recording in cleanroom environments, warn against exceeding established environmental conditions, and allow archiving of data on prevailing conditions for quality control and product safety monitoring purposes.

These

installations

are

based

on

industrial

automation

elements,

including

freely

programmable controllers equipped with operator panels. The software allows for parameter visualization and error signaling. Thanks to the communication systems based on Ethernet links, installations can be remotely managed.

ICS and RMS systems are usually part of an integrated building management system BMS and support the proper functioning of entire enterprises.

Industrial automation systems are subject to GMP validation procedures.

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SCOPE OF SOLUTIONS I&C and industrial automation, RMS & BMS, electrical installations.

RMS - Room Management Systems BMS - Building Management Systems I&C and industrial automation Door interlocking systems Cascade pressure control and management Air parameters registration and archiving systems and ICS security systems • • • •

Temperature control systems Humidity control systems Appropriate air exchange cycle control systems Air conditioning control systems

Other electrical installations

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

Technological exhaust systems for dust and gases. Explosion-proof dust removal systems. Elimination of volatile organic compounds.

Bart specializes in technological exhaust systems and dust removal systems. They help minimize or completely eliminate dust generated on the production line, monitor and separate suspended particles and active substances in the air, for example, during tablet production, grinding, and other substrate processing.

Dust removal systems at the source of their formation - along with a closed negative pressure transport system of pollutants - definitely protect against the movement of various dusts between rooms, and thus cross-contamination, and ensure the maintenance of technological rigor.

Technologies implemented by Bart also allow for proper filtration of toxic aerosols and gases that could endanger the health and life of employees during research and development work or during serial production using hazardous substances. Separate technologies are intended for adsorption of volatile organic compounds or their combustion RTO. In the case of contact with dust that can create a potentially explosive atmosphere in the air, Bart specialists offer ATEX-compliant protection, minimizing these risks.

Bart also offers a full range of specialized dust, gas, and vapor extraction arms, as well as Fumex digesters dedicated to laboratories, medical and healthcare facilities, allowing, for example, the extraction of patient aerosols.

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SCOPE OF SOLUTIONS E x h a u s t s y s te m s fo r d u s t a n d g a s e s .

Dust removal systems.VOC elimination.

•

Local and process dust removal systems

•

Central waste management systems

•

Digestor ventilation installations

•

•

•

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Local exhaust extraction installations extraction arms Process gas extraction installations Elimination of harmful volatile compounds, e.g. volatile organic compounds VOC

•

Adsorption installations, combustion with heat recovery

•

Removal of dust pollution in ATEX hazardous areas with security systems

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

Central vacuum and transport systems. Mobile vacuum cleaners.

Bart supports maintaining cleanliness in production or warehouse spaces through high-pressure extraction processes from technology, dust and solid waste vacuuming, and cleaning at workstations. They design “turnkey” central vacuum systems, the heart of which are high-quality filter ventilation devices, selected according to the user’ s process requirements. Bart offers devices of their own design and collaborates with leaders in this sector. In pharmaceutical production, efficient stationary vacuum cleaners with high-quality main filters and additional HEPA or ULPA filters are used.

For ad-hoc cleaning of workstations, as the exclusive representative in Poland, they recommend a wide range of industrial mobile vacuum cleaners from the Swedish company Dustcontrol, in standard execution and with non-sparking motors for vacuuming dust that creates an explosive atmosphere.

For the food industry, the company proposes adequate central vacuum systems designed for installation in zone 22 in accordance with the ATEX directive. They are accompanied by unique suction brushes designed for contact with food, tested, among other things, for the absence of migration of harmful substances, and a range of antistatic accessories. .

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SCOPE OF SOLUTIONS Central vacuum systems. Dust transport systems. Mobile vacuum cleaners.

•

Central dust extraction vacuum systems, ATEX certified included

•

Mechanical or negative-pressure transport systems for process dust

•

High-pressure extraction systems from production equipment

•

Mobile industrial vacuum cleaners, ATEX certified included

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SCOPE OF SOLUTIONS Clean Air & CleanRoom Engineering

Technological and peripheral installations for cleanroom zones.

The main installations that perform air conditioning functions - especially in terms of low solid particle content, temperature stability, and humidity - are accompanied by many other peripheral installations, such as lighting installations, fire protection, and alarm installations.

In addition to the main RMS or BMS system that provides constant, 24-hour control of parameters in rooms and supervision of the work of production or laboratory equipment, access control systems and other telecommunications installations are also needed.

Medical and technical gas installations are most often installed in hospitals, clinics, and other medical facilities, including installations of medical oxygen, nitrogen oxide, and carbon dioxide. Proper preparation of compressed air installations is a decisive factor in maintaining the required pressure parameters, efficiency, dew point temperature, solid particle content, and others.

In the pharmaceutical and biotechnological industries, Bart also provides the implementation of cryogenic installations, installations of liquid gases made in insulation with rubber insulation, with a protective jacket resistant to atmospheric factors, in vacuum insulation with straight or flexible pipes. Pipelines deliver liquids to portable tanks, thermoses, dewars, cryogenic pumps, or laboratory stations.

Equally important is the installation of purified water.

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SCOPE OF SOLUTIONS Technologycal and perypheral nstallations.

Electrical and lighting installations: • • • • • • • •

General lighting installation Alarm installation Power supply installation, emergency power supply Socket installation, distribution boards, Evacuation lighting installation External building and site lighting installation Brightness level control system Lightning protection installation, etc.

Other telecommunications installations: • • • • • • •

Access control system with card readers telephone installation Telephone and computer installation Data processing and storage system supervisory Intercom installation Iternal and external monitoring using CCTV system Burglary and assault signaling system Fire protection and smoke removal installations, etc.

Medical and technical gas installationsns: • • • • • • •

Compressed air Technical vacuum Medical oxygen Nitrous oxide Carbon dioxide Natural gas Helium, etc.

Cryogenic installations Purified water installations

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INDUSTRY EXPERTISE 28

Experience in a variety of industry sectors.

Expertise of BART Sp. z o.o. in selected industrial sectors

Pharmaceutical and medical industry Food industry Laboratories and scientific research centers Electronic and high-tech industry Automotive and aviation industry Plastics and packaging industry Chemical and technical industry

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INDUSTRY EXPERTISE Experience in a variety of industry sectors.

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INDUSTRY EXPERTISE 30

Experience in a variety of industry sectors.

Reference projects in the field of technology for cleanrooms Bart Sp. z o. o. has a rich portfolio of successfully implemented projects for clients representing various industries, including those that have used services and solutions dedicated to cleanrooms, promoted under the BT Cleanroom Engineering® brand. Among the references are: • general construction of a production-confectionery facility with high hygienic requirements in the pharmaceutical industry, including, among others, an executive project, construction, precise ventilation installations, accompanying installations, validation, and qualification DQ, IQ, OQ, PQ; • general construction of production clean rooms for packaging intended for the medical industry, along with precise ventilation and air conditioning installations, automation, and monitoring; • general construction of production and warehouse clean rooms for surgical dressings; • general construction of a set of laboratory clean rooms and dedicated internal installations for a scientific research unit dealing with photolithography of semiconductors; • execution in the “design and build” formula of ventilation and air conditioning installations, technological heat installations, and chilled water on the liquid forms production department in the pharmaceutical industry; • execution in the “design and build” formula of modernization of ventilation and air conditioning installations, dust extraction installations, c.t. and chilled water installations in the pharmaceutical dry forms production department; • execution in the “design and build” formula of mechanical ventilation and precise air conditioning installations with a pressure cascade in the rooms of the radio-pharmaceutical production center, isotope laboratories with open radioactive sources; • execution in the “design and build” formula of the enclosure of a set of clean rooms together with installations of ventilation, precision air conditioning, and automation for the production line of car windows with a laminating cabin.

You can obtain detailed information about the reference installations and constructions projects from specialists representing Bart Sp. z o.o. company. w w w. b t c l e a n r o o m . p l

INDUSTRY EXPERTISE Experience in a variety of industry sectors.

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INDUSTRY EXPERTISE 32

Experience in a variety of industry sectors.

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B T C l e a n ro o m E n g i n e e r i n g ®

ul. Będzińska 41/I, 41-205 Sosnowiec

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D e s i g n & E n g i n e e r i n g o ff i c e s : S o s n o w i e c , W r o c ł a w, W a r s z a w a , G d a ń s k

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© BA R T S p. z o. o.

B A R T S p. z o. o.