The Relevance of Containment Solutions in Chemical Industry
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The Relevance of Containment
Solutions in Chemical Industry
Regulatory Requirements and
Obstacles in Practice
Dr. Stefan Engel
Director Industrial Hygiene
Chief Medical Officer: Prof. Dr. med. Stefan Lang
Corporate Health Management
© BASF
Frankfurt,16 June 2021
Setting the Scene
Containment solutions play an important role in occupational health and
safety today …
and they will be even more important in the future.
2 June 2021
Internal
Outline of the Presentation
1. Regulatory Requirements
New and Revised Risk Concepts,
European and National Occupational Exposure Limit Values (OELs)
2. Containment Solutions
What Does "Technically Tight" Mean?
3. Implementation in Practice
Impact on Exposure Control Concepts
3 June 2021
Internal
Regulatory Requirements
Containment Solutions Play a Crucial Role in Risk Management
Europe: 2004/37/EC Carcinogens and Mutagens Directive, Art. 5(2)
4 June 2021
Internal
BOELV or Acceptable/Tolerable Concentration?
Assessing Cancer Risks in the Workplace
◼ Europe: 25 new BOELVs for carcinogens under CMD enacted since 2017 (currently CMD-4)
BOELVs …
are science-based (RAC)
determined under participation of the social partners (ACSH/WPC) including socioeconomic aspects
must be met
◼ Germany: new risk-based concept (risk acceptance model) since 2008 (publication of announcement
910)
Exposure-risk-relationships are risk-based (AGS)
Tolerable concentration (additional occupational cancer risk: 4:1.000) must be complied with.
Acceptable concentration (additional occupational cancer risk: 4:10.000) is to be inherited within 3 years after enacting.
6 June 2021
Internal
Thresholds Decreasing over Time
Challenges for Industry and Professional Use
2005 Today 2005 Today
TGC TGC
OEL
BOELV
OEL TC AC
0,5 0,2 0,02
0,5 0,006 0,01
0,006
mg/m3 mg/m3 mg/m3
Mn Compounds: Mn Compounds: Ni Compounds:
Inhalable Fraction Respirable Fraction Respirable Fraction
AC = Acceptable Concentration, TC = Tolerable Concentration
OEL = Occupational Exposure Limit (maximum permissible concentration)
TGC = Technical Guidance Concentration
7 22.06.2021
Internal
Containment Solutions
Technically Tight – Practical Aids for Implementation Controled General Ventilation Local Exhaust Ventilation
◼ OSH: Guidance on European level not established
◼ REACH: strictly controlled - rigorously contained
Open Handling Within Isolator or Closed Handling Within Isolator
e.g. ECHA, Guidance for Intermediates High Integrity Closed Coupling
◼ German TGD 500, annex 1
process indices for functional elements characterizing the level of
containment
◼ monographs (focus: pharmaceutical industry) Contained and Automated
Hirst et al., Containment Systems
Bässler, Lehmann, Containment Technology – Progress in the
Pharmaceutical and Food Processing Industry
International Society for Pharmaceutical Engineering (ISPE,
ECHA, Guidance on Intermediates, p. 16
Containment Manual)
8 June 2021
Internal
Containment Solutions
Technically Tight – Confusion of Terms
BA thesis* publication in "Gefahrstoffe – Reinhaltung der Luft"
* University of Applied Sciences Mannheim, Germany
◼ search in 829 German-language literature
EU Directives, German legislation, technical guidance documents (TRGS, TRBS,
TRAS), standards (DIN EN and similar) and scientific literature
◼ 197 terms describing tightness in 354 different citations identified
◼ often without precise definition (if any at all) - no harmonized use of
terms in different disciplines, e.g. in OSH or process safety
Dense Systems Require:
◼ Informed selection of suitable components.
◼ Perfect assembly. Gefahrstoffe 80 (2020) No. 11-12, S. 452 - 456
◼ Regular leakage checks and maintenance.
9 June 2021
Internal
Containment
German Presidency 2020 – STOP Cancer at Work
BAuA - Dokumentationen - EU-Konferenz "STOP dem Krebs am Arbeitsplatz" am 09.
Containment (baua.de)
und 10. November 2020 - Bundesanstalt für Arbeitsschutz und Arbeitsmedizin
10 22.06.2021
Internal
Implementation in Practice – Structured Aaproach
Exposure to be Controled from the "Milligram/m3 to the Nanogram/m3 range"
< 0,001 mg/m3
Ni and Ni compounds
0,001 – 0,01 mg/m3
Mn and Mn compounds
0,01 – 0,1 mg/m3 (respirable fraction)
0,1 - 1 mg/m3
1 - 5 mg/m3
Technology
11 June 2021
InternalTechnical Control Measures
Threshold Limit Value Met! – CMD Compliant?
© BASF SE © BASF SE © Hecht Technologie GmbH
Pneumatic Discharge Closed Big Bag Loading Closed Reactor Loading
no OEB classification ( "OEB 1") OEB 3 OEB 5 - 6
12 22.06.2021
InternalConclusion
Challenge for Industry and Professional Use
Industry and professional use must be prepared to effectively
control exposure from the milligram/m3 to the nanogram/m3 range.
13 22.06.2021
InternalTake Home Messages
◼ Industry and professional use is obliged to implement control measures according to the hierarchy
of controls required by European and national legislation.
◼ Continuously decreasing occupational exposure limit values are very challenging in practice and
will lead us in large scale chemical industry to the limits of feasibility.
◼ Effective containment solutions require …
informed selection of components (substance, aggregate state, process conditions, material
stress
perfect assembly and regular maintenance
leakage checks (regular monitoring of leakage rates)
◼ In any case flexible combination of all types of controls (including personal protective equipment,
e.g. for short-term exposure) is necessary.
14 June 2021
InternalInternal
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