Exhaust Technology for the Pharmaceutical, Chemical, and Medical Technology Industries – Controlled Emissions Monitoring
Extraction Technology for the Pharmaceutical, Chemical, and Medical Technology Industries—Tailored to the Material, Process, and Purity Requirements
Powders, Fine Dust, aerosols, and vapors can be released during weighing, dosing, mixing, grinding, tableting, coating, filling, or cleaning. In the medical technology sector, emissions from additive manufacturing, laser processing, grinding, and polishing are also a concern. In addition to worker protection, product purity, cross-contamination, material compatibility, and, where applicable, fire or explosion hazards must be taken into account.
EVOTEC tailors the collection, airflow capacity, filter or adsorption stages, discharge, and system integration to the specific substance, process, and spatial layout—whether for individual workstations, machines, or permanently connected production lines.
Your advantages in the pharmaceutical, chemical, and medical technology industries:
Measuring Emissions Directly at the Source
Dust, particles, aerosols, vapors, and fumes are captured during the process before they can spread into the work area or product area.
Supporting purity and material separation
Well-defined collection, low-contamination discharge, and appropriate cleaning procedures reduce deposits and cross-contamination.
Design a safety and filtration concept tailored to the specific material
Particulate filters, sorption stages, material selection, ESD protection, and explosion protection are determined based on material data, the process, and a hazard assessment.
At which stage of the process do you generate powders, particles, aerosols, vapors, or fumes? Please provide us with details regarding the material, safety data, release point, operating duration, and purity requirements. We will work with you to review the containment system, filtration technology, and system integration.
What types of emissions are generated in the pharmaceutical, chemical, and medical technology industries?
It is not the industry alone, but rather the material and the process that determine the extraction concept. Wirk- und Hilfsstoffe, Zwischenprodukte, Lösemittel, Reinigungsmedien, Metall- oder Kunststoffpulver und Bearbeitungsrückstände können sehr unterschiedliche Gesundheits-, Qualitäts-, Brand- und Explosionsrisiken besitzen.
Powders, active ingredients, and fine particles
Fine powders may be released during weighing, transfer, dosing, mixing, granulation, grinding, tableting, and filling. Dust generation characteristics, particle size, occupational exposure limits or internal containment targets, and potential sensitization determine the methods used for collection and separation.
Vapors, Aerosols, and Machining Emissions
Liquid formulations, coating, cleaning, or filling can generate aerosols and gaseous emissions. In medical technology, laser processing, additive manufacturing, grinding, and polishing also produce fume and fine particles. Particles and gases require different separation methods.
The design process begins with safety data sheets, substance and process data, and the actual release pathway. Visibility or odor alone are not sufficient for the assessment; purity, cleaning, and documentation requirements are also taken into account.
Where does effective data collection begin?
Emissions are captured as close as possible to the point of origin or discharge. Enclosures, machine connections, and correctly positioned capture elements limit the spread of emissions and reduce the required airflow rate. TRGS 500 distinguishes, among other things, between integrated, highly effective, and other types of extraction systems, as well as source extraction directly at the point of origin.
Weighing, Dosing, Mixing, Transfer, and Filling
Closed or semi-open collection systems are particularly effective for emptying bags, drums, or containers; weighing; feeding mixers; transferring powders; and filling. Transfer points, airlocks, and discharge points are designed to prevent dust from escaping into the work area or product area.
Additive Manufacturing, Laser Processing, and Surface Treatment
In metal or plastic printing, depowdering, screening, laser cutting, laser welding, marking, grinding, and polishing, the monitoring process must take into account tool movement, component geometry, process gas, and particle streams. Rework and cleaning require a separate, material-specific approach.
How are particles, vapors, and residues handled safely?
Capture, piping network, separation, discharge, and disposal form an integrated system. The system’s design is determined by factors such as particle or gas phase, toxicity, moisture content, stickiness, reactivity, flammability, material compatibility, and the desired air recirculation rate.
Closed-loop control and defined operating point
Enclosures, extraction booths, machine connections, and locally adjusted extraction reduce by-pass air and improve extraction efficiency. Airflow, negative pressure, and pressure drop are set so that the process remains stable and room pressure or the ventilation system are not affected in an uncontrolled manner.
Particulate filter and low-contamination discharge
Filter area, separation efficiency, cleaning, and discharge depend on the material, dust volume, and risk level. Depending on the application, fine-particle or airborne particle filters, enclosed collection systems, and low-contamination filter changes may be required. A single H13 or H14 filter element is no substitute for a properly designed complete system.
Gaseous Substances and Activated Carbon
Particulate filters do not reliably remove gases and vapors. Depending on the substance, controlled exhaust air routing or appropriate sorption stages may be considered. Activated carbon is selected based on the substance and volume; contact time, humidity, temperature, loading, and replacement before breakthrough must be taken into account.
Material Separation, Cleanability, and Disposal
Separate systems or clearly defined cleaning and replacement procedures reduce cross-contamination between products and substance groups. Smooth, accessible surfaces, low-dust filter replacement, enclosed discharge points, and appropriate disposal containers facilitate cleaning and maintenance.
Important: Substances must not be vacuumed together solely because they have a similar consistency. Chemical compatibility, hazardous reactions, the risk of contamination, and disposal methods must be assessed in advance.
Stationary Process Exhaust and Mobile Cleaning
Stationary Systems for Machines and Production Lines
Stationary systems are suitable for continuous processes, defined machine connections, and multiple data collection points. They can supply dosing units, mixers, tablet presses, filling lines, processing machines, laser cells, or additive manufacturing areas and can be monitored centrally.
Mobile Solutions for Cleaning, Maintenance, and Special Cases
Mobile vacuum cleaners support controlled cleaning, batch changes, maintenance, tool changes, and localized work. Their suitability depends on the material, dust class, disposal plan, room specifications, and any potential EX zone. A hygienic design or ESD features alone do not replace a comprehensive risk assessment.
Decentralized or centralized exhaust
Decentralized systems limit material flow paths and facilitate product or batch separation. Centralized systems can serve multiple similar processes. The concurrency factor, piping network, pressure loss, access for cleaning, material separation, and emergency response plan determine the appropriate architecture.
Cleanrooms, Room Pressure, and Contamination Control
In cleanrooms and controlled areas, every exhaust system affects the air balance. Airflow measurement and system performance are coordinated with room pressure, supply air, airlocks, and the cleaning strategy. Annex 1 of the EU GMP Guidelines classifies equipment, rooms, procedures, and monitoring as components of a comprehensive contamination control strategy.
This distinction is crucial: stationary systems capture emissions during ongoing processes; mobile devices handle flexible cleaning and maintenance tasks. The extraction technology supports the hygiene and contamination control concept, but does not, on its own, ensure GMP or cleanroom compliance.
What does the interpretation depend on?
A reliable design requires specific information regarding the substance, safety data, type of emission, release point, production volume, operating duration, containment objective, room class, and desired system integration.
Substance Data, Threshold Limits, and Risk Assessment
Health hazards, occupational exposure limits or internal exposure targets, sensitization, flammability, explosion parameters, reactivity, temperature, and potential interactions must be assessed. Only then can the filtration stages, safety design, choice of materials, and disposal method be determined.
Process Data, Containment, and Plant Integration
The technical design is determined by the capture geometry, opening areas, air flow rate, negative pressure, ductwork, filter cleaning, discharge, monitoring, cleanability, and interfaces with the machine or building management system.
Before commissioning and on a recurring basis, verify that the collection system, airflow, filter monitoring, and safe disposal are functioning properly under actual operating conditions. Changes to the formulation, product, batch, or process may require a reassessment.
Which extraction technology is right for your pharmaceutical, chemical, or medical technology process?
Please provide us with the process steps, substances, safety data, release point, production volume, operating duration, and space and cleanliness requirements. EVOTEC will use this information to develop a suitable stationary or mobile exhaust system.
Properly Classifying Explosion Protection, ESD, and Material Compatibility
Flammable dusts, gases, vapors, or hybrid mixtures can pose an explosion hazard. Whether an explosive atmosphere can form and what measures are required depend on the substance’s properties, release rates, and a risk assessment in accordance with TRGS 720. ESD measures can reduce electrostatic charging but do not automatically provide complete explosion protection.
Relevant Exhaust Applications in the Pharmaceutical, Chemical, and Medical Technology Industries
Every process has different requirements for data acquisition, filtering, and safe operation. Select the appropriate process solution to view technical details and suitable device concepts.
Fine dust extraction
For active and excipient powders, chemical intermediates, and fine processing residues during weighing, dosing, mixing, filling, and cleaning.
EX-protected extraction
For processes in which flammable dusts, vapors, or hybrid mixtures must be safely controlled following a risk assessment.
Fume and steam extraction
For solvent, coating, cleaning, and other gaseous emissions that cannot be captured using particulate filters alone.
Exhaust Systems in Additive Manufacturing
For metal and plastic powders used in printing, depowdering, screening, post-processing, and cleaning of medical device components.
Laser Fume Extraction
For laser cutting, laser welding, texturing, and marking with detection directly at the processing zone or laser cell.
Is your pharmaceutical, chemical, or medical technology process not listed?
Describe the process step, substance, and emission to us. We’ll determine which collection and filtration solution is best suited for your application.
Frequently Asked Questions About Exhaust Systems in the Pharmaceutical, Chemical, and Medical Technology Industries (FAQ)
What types of emissions are generated in the pharmaceutical, chemical, and medical technology industries?
Depending on the process, active and auxiliary ingredient powders, chemical intermediates, Fine Dust, aerosols, solvent or cleaning vapors, as well as emissions from laser cutting, grinding, and polishing may be generated. The actual composition is determined by substance data, the formulation, the material, and process parameters.
When is a stationary extraction system a good idea?
Stationary systems are appropriate when machines, production lines, or multiple collection points are permanently connected, when operations are continuous, or when airflow and filter condition need to be monitored centrally. The ductwork and the simultaneous operation factor are designed for actual operating conditions.
When is a mobile extraction solution the better choice?
Mobile solutions are suitable for cleaning, batch changes, maintenance, rework, and changing work locations. Their suitability depends on the material, dust class, disposal plan, cleanability, space requirements, and potential explosion protection needs.
Is an EX system always required for these processes?
No. The key factor is whether flammable dusts, gases, or vapors can occur in hazardous concentrations. Substance characteristics, release rates, and operating conditions determine whether zones and additional explosion protection measures are required.
Does an H or HEPA filter automatically make a system GMP-compliant?
No. An H or HEPA filter describes a specific filtration or separation performance, not the GMP compliance of the entire process. Design, plant construction, cleanability, discharge, room layout, qualification, monitoring, and operational procedures must be evaluated collectively.
Ihr Partner für industrielle Absauglösungen
EVOTEC develops stationary extraction systems and mobile solutions for sensitive industrial manufacturing processes. From individual extraction points to networked production facilities, airflow capacity, filtration technology, material separation, monitoring, and safety features are tailored to the pharmaceutical, chemical, and medical technology industries.
Commissioning
Maintenance
Which extraction solution is right for your pharmaceutical, chemical, or medical technology process?
Please provide us with details regarding the process steps, materials, safety data, release point, production volume, operating duration, space and cleanliness requirements, as well as any potential fire or explosion hazards. EVOTEC will assist you in designing a suitable solution.
Robin Buschbaum
Sales D/A/CH
Specialist for extraction technology
vertrieb@evo-products.de
02642 9373-53
Lars Blankenburg
Sales
lars.blankenburg@evo-products.de
02642 9373-10
Asim Zaman-Pahlke
Export Sales
export@evo-products.de
02642/9373-15