Lab container consulting – needs analysis, concept, delivery
The LBO of Germany’s 16 federal states, BImSchG, GenTG, Biological Agents Ordinance, ArbSchG and fire-protection concepts — we guide you through every authority path in Germany, Austria and Switzerland.
Specialised in permit questions around modular lab containers: BSL-2/3, GMP, ATEX, fire-protection concept, regional-planning/building-authority path. No general construction advice, no residential or commercial-building topics.
Permits for lab containers: LBO, BImSchG and BioStoffV
Siting a lab container requires coordination across several areas of law: building law (LBO of the 16 federal states), immission control (BImSchG), biological-agents law (BioStoffV), genetic-engineering law (GenTG), occupational safety (ArbStättV, GefStoffV) and fire protection (MBO/LBO). Each path has its own deadlines, documents and competent authorities.
For every project Planexus prepares a permit roadmap with milestones: which permits are required, which documents are needed, which authority is competent, which deadlines apply? The roadmap is agreed with the client and used as the project-management baseline.
On BSL-3 projects we coordinate in parallel the BioStoffV permit process (§ 15) with the ZKBS secretariat, the building-law permit process and the ArbSchG risk assessment. On GMP projects we accompany authority communication with BfArM, Swissmedic or BASG in parallel with the building-law clarification.
Our consulting services
Building law
Advice on building-law requirements and support with the building permit.
Occupational safety
Compliance with the Workplace Ordinance and risk assessment.
Permit procedures
Preparation and accompaniment of all required permits.
Standards expertise
Ensuring conformity with DIN, EN and ISO standards.
Building-law consulting
The building-law classification of lab containers is not always clear-cut and depends on several factors: is the container sited permanently or temporarily? Does it constitute a building in the legal sense? Which occupancy class applies?
Permit-free siting
In many cases lab containers can be sited without a permit — particularly for temporary use or when they are classed as a movable item. We check the prerequisites and advise you on the best approach.
Building permit
Where a building permit is required, we support you in preparing all necessary documents: application forms, site plan, floor plans, elevations, building description, structural calculations and fire-protection concept. We accompany the procedure and act as the point of contact for the authorities.
Development-plan conformity
Siting a lab container must be compatible with the development plan. We check the planning-law prerequisites and identify routes by which your project can be realised — even if the development plan appears to speak against it at first glance.
Occupational health and safety
Laboratories are workplaces with particular hazards. Compliance with occupational-safety regulations is therefore not only a legal duty, but also an expression of the duty of care towards your staff.
We advise you on every aspect of occupational safety in the laboratory:
- Workplace Ordinance (ArbStättV) and Technical Rules (ASR)
- Hazardous Substances Ordinance (GefStoffV) and TRGS
- Biological Agents Ordinance (BioStoffV) for laboratories with biological agents
- Radiation Protection Ordinance (StrlSchV) for isotope laboratories
- Industrial Safety Ordinance (BetrSichV) for pressure equipment and lifts
- Risk assessment under the Occupational Safety and Health Act
Environmental-law requirements
Laboratories can have significant environmental impacts — from emissions of hazardous substances to wastewater and waste disposal. Compliance with environmental-law requirements is therefore an important aspect of planning and operating a lab container.
Immission control: We advise you on the requirements of the Federal Immission Control Act (BImSchG) and check whether an immission-control permit is required for your laboratory. Our ventilation and extract systems are designed so that limit values are reliably met.
Water law: Discharge of laboratory wastewater into the sewer is subject to strict regulations. We advise you on wastewater treatment and support you in obtaining the water-law permit.
Waste law: Proper disposal of laboratory waste is regulated by law. We help you prepare a waste concept and introduce you to certified disposal contractors.
Special permits for particular laboratories
Depending on the type of laboratory, special permits may be required:
S1 to S4 laboratories: For work with genetically modified organisms you need a permit under the Genetic Engineering Act. We advise you on the structural and organisational requirements of the various protection classes.
BSL-2 and BSL-3 laboratories: Laboratories for work with hazardous biological agents require a notification or permit under the Biological Agents Ordinance. We support you in preparing the required documents.
Isotope laboratories: Handling of radioactive substances requires a permit under the Radiation Protection Ordinance. We advise on the structural design and the required protective measures.
Pharmaceutical manufacture: Laboratories for the manufacture of medicinal products are subject to GMP (Good Manufacturing Practice). We advise on the structural requirements and the qualification of the rooms.
Fire protection
Fire protection is a central topic in the planning and permitting of lab containers. We prepare fire-protection concepts that meet the requirements of the building code and the industrial-building guideline.
Our fire-protection concepts cover structural, technical and organisational fire protection. From fire-resistant construction via fire-alarm systems to escape- and rescue-route plans — we agree the concept with the competent fire-protection authorities.
Authority paths by sector and containment level
The permit strategy follows the intended use. For lab containers for pharma & biotech we coordinate BfArM/Swissmedic requirements in parallel with the LBO review. Public-health and emergency-preparedness laboratories additionally need BioStoffV notifications and, where applicable, BSL-3 permits under § 15 BioStoffV with ZKBS coordination. For oil, gas and refinery laboratories we integrate the explosion-protection document, AwSV and, where applicable, BImSchG.
Each authority path is documented with a checklist: LBO building application, BImSchG notification, BioStoffV notification/permit, GenTG S1–S4 permit, fire-protection concept to MBO/LAR and risk assessment under ArbSchG. ATEX projects to EN 60079 receive a separate explosion-protection document. GMP containers reference EU GMP Annex 1 and Annex 15 for the qualification documentation.
In Austria analogous paths apply via OIB guidelines and the BMSGPK; in Switzerland via cantonal building codes, the ESV (genetic engineering) and Swissmedic (GMP). We know the country-specific features of all 16 German LBOs, the 9 Austrian state building codes and the 26 cantonal building regulations in Switzerland.
Complimentary initial consultation
Let us discuss the legal requirements for your laboratory project. No obligation, complimentary.
Request a consultationOur expertise
- Building law & permits
- Occupational health & safety
- Environmental law
- Genetic-engineering law
- Radiation protection
- Fire protection
Frequently asked questions on consulting & permits
Does a lab container need a building permit?
That depends on siting duration, the state building code (LBO) and the intended use. Temporary siting of up to 3–6 months is permit-free in many federal states if the container is classed as a movable item. Permanent siting or BSL-3 use typically requires a building application with a site plan, structural-stability evidence, fire-protection concept and, where applicable, a deviation application. We check the state-specific LBO for every location in DE, AT and CH and prepare the documentation.
When does the BImSchG apply to lab containers?
The Federal Immission Control Act (BImSchG) becomes relevant when the container generates emissions beyond Annex IV of the BImSchG — e.g. extract air from fume cupboards with organic solvents, combustion plant or larger refrigeration plant. For standard laboratories with DIN EN 14175 fume cupboards and extract to atmosphere, a notification under § 15 BImSchG is often sufficient. For BSL-3 laboratories with HEPA-filtered extract we check whether a 4th BImSchV permit is required.
What requirements does the BioStoffV place on container laboratories?
For work with biological agents in protection classes 2 and 3, BioStoffV §§ 14–15 apply. BSL-2 requires a notification to the competent occupational safety authority with a structural and organisational safety concept. BSL-3 requires a permit under § 15 BioStoffV with evidence of directional airflow, personnel airlock, autoclave, emergency shower and dual HEPA filtration. We prepare the complete notification or permit file including the risk assessment under the ArbSchG.
How does a permit procedure for GMP containers proceed?
GMP containers do not need a separate building permit for GMP conformity — that is assessed by the competent authority (BfArM, Swissmedic, BASG) as part of the manufacturing authorisation or clinical-trial review. Our consulting covers preparation of Annex 1 documentation, the CCS concept, cleanroom qualification (IQ/OQ/PQ) and authority communication. In parallel we clarify building-law questions (LBO) and immission-control requirements (BImSchG).
Does Planexus also advise on ATEX permits for lab containers?
Yes. ATEX areas to EN 60079 require explosion-protection documentation under the BetrSichV and ATEX Directive 1999/92/EC. We prepare zoning (Zone 0/1/2), document ignition sources, and design explosion-protected equipment and ventilation concepts for flammable gases or vapours. The documentation is integrated into the ArbSchG risk assessment and, where required, coordinated with the competent occupational safety authority.
How long does a BSL-3 permit procedure take in Germany?
BSL-3 under BioStoffV § 15 requires a permit from the competent occupational safety authority. With a complete file (risk assessment, structural concept, safety concept, organisation plan) the procedure takes 8–12 weeks. In parallel, the ZKBS notification is submitted to the competent federal authority. We prepare all documents and accompany authority meetings. Missing documents extend the procedure by 4–8 weeks — which is why we start authority coordination in parallel with works planning.
Legal certainty for your laboratory project
With our support you clear every regulatory hurdle. Contact us for a no-obligation initial consultation.
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