Lab containers for pharma & biotech – GMP, cleanroom, ISO
Cleanroom containers Class 8/7/6 (GMP Grade D/C/B background), BSL-2/3 containers to TRBA 100/120, complete GMP qualification documentation IQ/OQ/PQ, Annex 1-compliant pressure cascades with HEPA H14 dual filtration. We build for the German, Swiss and Austrian pharmaceutical and biotech industry – inspection-ready for BfArM, Swissmedic and BASG from the Albstadt factory.
While you are still planning the conventional cleanroom, qualification is already under way with us.
Planexus Engineering Team
Content is owned by the Planexus engineering team — civil engineers, process engineers and laboratory planners with specialised experience in modular laboratory construction. Planexus GmbH is part of Wesemann Holding GmbH and delivers BSL-2, BSL-3, GMP and ATEX containers for pharma, biotech, research and crisis units across DACH.
Why pharma and biotech companies choose modular containers over stick-build
In pharma and biotech, the speed from idea to first validated batch decides the value of a project. Conventional cleanroom construction takes 12–18 months. Modular GMP containers from Planexus deliver the same validated cleanroom in 18–24 weeks.
The three bottlenecks where pharma container projects regularly fail
The revised Annex 1 of 22 August 2022 requires a written Contamination Control Strategy (CCS), a Pre-Use Post-Sterilisation Integrity Test (PUPSIT) for sterilising filters, documented aerodynamic smoke studies in Grade A, and continuous particle and microbial monitoring to ISO 14644-2. A container that only delivers “cleanroom Class 8” will fail inspection.
Planexus response: CCS template and PUPSIT concept from the factory.
Many container suppliers deliver “GMP-capable” units without IQ/OQ/PQ documentation. On site, an external validation contractor then has to complete the full qualification over 12–16 weeks – without access to factory data. That delays GMP release by half a year.
Planexus response: FAT with complete IQ/OQ pre-documentation, PQ on site at handover.
A GMP manufacturing authorisation under AMG § 13 in Germany requires notification to the competent Land authority (for example a Regierungspräsidium or Bezirksregierung), which then calls in BfArM inspectors. In Switzerland the route runs via Swissmedic, in Austria via BASG. Organising this in parallel with construction saves 8–12 weeks.
Planexus response: pre-inspection with the authority, together with your QP.
Which standards and regulations we implement for pharma and biotech containers
| Standard / framework | Application | Planexus delivery |
|---|---|---|
| EU GMP Annex 1 (22.08.2022) | Sterile medicinal products, Contamination Control Strategy | CCS template, PUPSIT concept, airflow visualisation |
| EU GMP Annex 11 | Computerised systems, audit trail | GAMP 5-compliant BMS/EMS with electronic signature |
| EU GMP Annex 15 | Qualification and validation | URS, DQ, FAT, SAT, IQ, OQ, PQ in full |
| ISO 14644-1/-2/-3 | Cleanroom classes 1–9, monitoring, test methods | Classes 5–8 with particle measurement and recovery time |
| ISO 14698-1/-2 | Biocontamination, active/settle plates | Microbial monitoring concept including alert/action limits |
| DIN EN ISO 14644-4 | Design, construction, start-up | Pressure cascade, air changes ≥20–60/h, HEPA H14 |
| DIN 1946-4 | HVAC for medically used rooms | Ia/Ib/II design with hygiene certificate |
| TRBA 100 / TRBA 120 | Protective measures, containment levels 2/3 | BSL-2/3 containers with airlock and autoclave |
| BioStoffV § 15 | Risk assessment for biological agents | Zoning and authorisation documentation |
| GenTG / GenTSV | Genetic-engineering facilities S1/S2/S3 | ZKBS notification, GenTAufzV documentation |
| ICH Q9 / Q10 | Quality risk management, PQS | FMEA risk analysis and quality by design |
| 21 CFR Part 11 | FDA: electronic records / signatures | Audit trail, access rights, data integrity |
The table shows only the core frameworks. For each application – for example cell and gene therapy under the ATMP regulation, HPAPI handling to ISPE Risk-MaPP, or medical-device contract manufacture to ISO 13485 – we add product-specific standards.
Eight typical pharma and biotech container applications that Planexus supplies
Grade C background with Grade A isolator, lyophilisable vials, PUPSIT filters, Annex 1-compliant airflow visualisation.
High-potency API with OEB 4/5 containment, isolator with transfer concept, dedicated extract with activated-carbon stage.
Grade A cabinet in Grade B background, single-use bioreactor, closed-system workflow, EU Regulation 1394/2007.
Risk group 3 pathogens with negative-pressure cascade −25 / −50 Pa, HEPA H14 dual filtration, autoclaved airlock.
Sterility testing, bioburden, endotoxin LAL test, mycoplasma detection, ISO Class 7 with local Class 5.
HPLC, GC, IR/UV/Vis, IPC laboratory with GMP-relevant data integrity to 21 CFR Part 11 and Annex 11.
Phase I/II/III contract manufacture under EU Regulation 536/2014 with GMP authorisation and QP release per batch.
Standardised utility interfaces with product-specific interchangeable container modules for flexible contract manufacture.
Six engineering details by which inspectors recognise a pharma container
Reproducible differential pressures to DIN EN ISO 14644-4
Grade D airlock +5 Pa to the exterior, Grade C room +15 Pa to the airlock, Grade B room +30 Pa to the Grade C airlock. For BSL-3 inverted pressure at −25 / −50 Pa. Manometers permanently installed, trend recording in the BMS.
H14 to EN 1822-1, ≥99.995 % @ MPPS
Pre-filters F7/F9 in the air-handling unit, terminal H14 in the cleanroom ceiling. Bag-in-bag-out for BSL-3 filter changes without contamination exposure. Annual DEHS test to ISO 14644-3 for filter integrity.
Smoke study to Annex 1 §4.30
Fog test with theatrical smoke or DEHS aerosol, video recording of the Grade A zone in dynamic operation, documented evidence of laminar flow at critical points. We supply the smoke study as part of OQ.
Cleanroom wall systems, coving, GMP flooring
Smooth, abrasion-resistant surfaces resistant to H₂O₂ and PAA decontamination, coved junctions wall/floor and wall/ceiling, seamless rubber or epoxy floors with proven chemical resistance to DIN EN ISO 175.
Integrated VHP / H₂O₂ gassing
Prepared docking points for VHP generators, closed HVAC bypass dampers, biological-indicator holders at reproducible positions, cycle development for 6-log spore inactivation to ISO 22441.
21 CFR Part 11 and Annex 11 implemented
Audit trail in all GxP-relevant systems, electronic signatures with two-factor authentication, backup to a separate server with daily mirroring, media encryption, role-based access to ISO 27001.
Where Planexus supplies pharma and biotech containers in DACH
Industriepark Höchst, the Rhineland pharma corridor, Berlin-Buch campus, Munich-Martinsried biotech cluster, Hamburg pharma and diagnostics sites.
Basel as a pharma capital, diagnostics at Rotkreuz near Zurich, Bern with the FOPH (BAG) and Swissmedic on site.
Vienna biotech cluster with AGES and BASG, Linz chemical park.
Which cleanroom class does my pharma laboratory need?
Cleanroom class follows the process, not the budget. EU GMP Annex 1 (status 22 August 2022) maps ISO 14644-1 classes to GMP grades: ISO Class 8 = GMP Grade D (≤3,520,000 particles ≥0.5 µm/m³ at rest) for non-critical areas, packaging and storage. ISO Class 7 = GMP Grade C (≤352,000 particles ≥0.5 µm/m³) for formulation, preparation and the background to aseptic areas. ISO Class 5 = GMP Grade A (≤3,520 particles ≥0.5 µm/m³) for aseptic filling, isolators and RABS – in a container typically via a laminar-flow bench or isolator in a Class 7 background.
Decision matrix: QC microbiology (sterility, bioburden) → Class 7 with local Class 5 at the cabinet. Sterile vial filling → Class 7 background + Class 5 isolator/RABS. HPAPI handling OEB 4/5 → Class 8 with isolator containment, separate activated-carbon extract. Non-sterile API synthesis → Class 8 or 7 depending on endotoxin requirements. ATMP cell and gene therapy → Class 7 background + Class 5 cabinet under EU Regulation 1394/2007. BSL-2 biotech research → no GMP cleanroom, but TRBA 100/120 with a Class II microbiological safety cabinet.
Air-change rates: Class 8 ≥20/h, Class 7 ≥40/h, Class 5/6 ≥60/h. Pressure cascade: airlock +5 Pa, production +15 Pa, aseptic zone +30 Pa (positive) or BSL-3 inverted −25/−50 Pa. Planexus sizes the class from your CCS (Contamination Control Strategy) – not the other way round.
Cleanroom container costs: price ranges and drivers
Price ranges ex works Albstadt (2026, including HVAC, HEPA H14, standard IQ/OQ qualification): ISO Class 8 (GMP Grade D): €4,500–7,500 per m² of cleanroom area. ISO Class 7 (GMP Grade C): €6,500–9,500 per m². Local ISO Class 5/6 (isolator/RABS in a Class 7 background): €8,000–12,000 per m² including isolator interface. BSL-3 containers extra: +30–50 % for negative-pressure cascade, bag-in-bag-out and autoclaved airlock. Stick-build comparison: €8,000–15,000 per m², construction period 12–18 months.
Cost drivers: cleanroom class (each step +25–40 %), area (scale effect from 40 m²), validation scope (full IQ/OQ/PQ vs IQ/OQ only), isolator/RABS integration (+€80,000–250,000), VHP decontamination (+€25,000–60,000), BSL-3 engineering (+€150,000–400,000). Hire model: €6,500–14,000 per month for a Class 8 container of 30 m², €12,000–22,000 per month for Class 7. CDMO platform with standard interfaces: payback from three interchangeable modules versus stick-build conversions.
Planexus services for pharma & biotech
Technical laboratory planning
Annex 1 CCS template, ISO 14644 cleanroom-class sizing, pressure cascade, BSL-2/3 zoning, URS through DQ to Annex 15.
Modular construction & manufacturing
GMP cleanroom containers Classes 5–8, HEPA H14 dual filtration, VHP docking points, BfArM/Swissmedic inspection-ready from the Albstadt factory.
Laboratory equipment
Isolator/RABS interfaces, laminar-flow benches, EN 285 autoclave, particle monitoring to ISO 14644-2, GAMP 5-compliant BMS/EMS.
Further reading on pharma and biotech containers
GMP cleanroom in a container: pharmaceutical production in a compact footprint
What GMP-compliant container cleanrooms deliver, what they cost, and where the limits lie.
BSL-2 and BSL-3 in a container: is it possible?
Containment levels in container construction – how the highest biosafety requirements are met.
HVAC, ventilation and standards
DIN 1946-7, TRGS 526, air-change rates, HEPA filtration and energy efficiency in detail.
Frequently asked questions on pharma & biotech
Are GMP cleanroom containers even permissible under EU GMP Annex 1?
Yes. EU GMP Annex 1 in the revised version of 22 August 2022 (in force since 25 August 2023) does not prescribe a particular construction method; it requires an effective Contamination Control Strategy (CCS). Modular container cleanrooms meet Annex 1 requirements provided that cleanroom classes to ISO 14644-1 (Grades A/B/C/D corresponding to ISO 5/7/8/9), pressure cascades, HEPA H14 filtration, material and personnel airlocks, monitoring to ISO 14644-2 and complete qualification documentation (URS, FAT, SAT, IQ, OQ, PQ) are in place. Germany’s federal authority BfArM, Swissmedic in Switzerland and Austria’s BASG regularly accept modular cleanroom containers in manufacturing-authorisation procedures under AMG § 13 (DE), the Therapeutic Products Act (HMG, CH) or the Austrian Medicines Act (AMG, AT). We supply complete Annex 1 documentation packs including a CCS template.
Which cleanroom classes can be delivered in container construction?
The standard is ISO 14644-1 Class 8 (GMP Grade D, ≤3,520,000 particles ≥0.5 µm/m³ at rest) and Class 7 (GMP Grade C, ≤352,000 particles ≥0.5 µm/m³). For aseptic filling under Annex 1 you also need local Class 5 (GMP Grade A, ≤3,520 particles ≥0.5 µm/m³) – typically realised via a laminar-flow bench, isolators or RABS, with a Class 7 or 8 container background. Class 6 is achievable with dual-filter ceilings (H13 + H14) and air-change rates of ≥60/h. We build for Classes 5/6/7/8 from the Albstadt factory with certified particle measurement to ISO 14644-1, documented recovery time to ISO 14644-3 and complete cleanroom qualification.
How long does GMP qualification of a container cleanroom take?
The qualification workflow follows the V-model: URS → DQ → FAT → SAT → IQ → OQ → PQ. At Planexus, URS through FAT run in parallel with factory production in Albstadt – saving 4–6 weeks versus a conventional stick-build. Typical timeline: URS workshop 1 week, design qualification 2 weeks, factory production with FAT 8–10 weeks, logistics 1 week, SAT on site 1 week, IQ 1–2 weeks, OQ 2–3 weeks, PQ 3–4 weeks. Overall duration from kick-off to GMP release: 18–24 weeks. A conventional stick-build of comparable scope takes 36–48 weeks. Time saving is the main reason pharma and biotech customers choose modular containers – not price.
Can containers be used for BSL-2 and BSL-3 in biotech research?
Yes, with constraints by containment level. BSL-2 to TRBA 100/120 is standard in container construction – Class II microbiological safety cabinet (DIN EN 12469), autoclave, personnel airlock, emergency shower, eyewash station, separate hazardous-substance and waste streams. BSL-3 is more demanding: directional airflow with controlled negative pressure (typically −25 Pa to the airlock, −50 Pa to the exterior), HEPA H14 dual filtration in supply and extract with bag-in-bag-out, autoclaved material and personnel airlocks, emergency-power backup for ventilation and light traps, redundant safety chain, annual filter integrity testing. BSL-3 requires authorisation under BioStoffV § 15 in Germany, the Containment Ordinance (ESV) in Switzerland and GTG/BBG in Austria – notification runs via the ZKBS secretariat (DE), FOEN/BAFU (CH) or BMSGPK (AT). We build BSL-3 containers with complete authority documentation.
What does a GMP cleanroom container cost compared with conventional cleanroom construction?
GMP cleanroom containers to ISO 14644 Class 8 (GMP Grade D) sit between €4,500 and €7,500 per square metre of cleanroom area, including HVAC, filters, pressure cascade and standard qualification. ISO Class 7 (GMP Grade C) sits between €6,500 and €9,500 per square metre. A conventional stick-build in an existing building typically costs €8,000–15,000 per square metre, plus a 12–18 month construction period and temporary production loss. The container solution is therefore not necessarily cheaper per square metre – it is dramatically faster. In pharma, time is usually the decisive lever: every week of faster market authorisation or every week of an earlier clinical batch counts directly in the business case.
Which industry standards must a pharma container meet?
Mandatory for GMP pharma: EU GMP Guide Part I (medicinal products) and Part II (active substances), EU GMP Annex 1 (sterile medicinal products, status 22 August 2022), EU GMP Annex 11 (computerised systems), EU GMP Annex 15 (qualification and validation), ISO 14644-1/-2/-3/-4 (cleanroom classes), ISO 14698 (biocontamination), DIN EN 16798 (ventilation), DIN 1946-4 (HVAC for medically used rooms), VDI 2167 (hospital ventilation) and ICH Q9/Q10 (quality management). For GxP computerised systems additionally GAMP 5 and 21 CFR Part 11. For biotech with genetically modified organisms: GenTG/GenTSV (DE), ESV (CH), GTG (AT). For investigational medicinal products, GCP-V and EU Regulation 536/2014 in addition. We supply a declaration of conformity and complete qualification documentation for each standard.
Do container cleanrooms also work for CDMOs and contract manufacture?
Modular container cleanrooms are particularly well suited to CDMOs. A CDMO needs product-specific cleanroom configurations for each contract – sometimes sterile filling, sometimes lyophilisation, sometimes HPAPI handling, sometimes cell and gene therapy. Containers let you use the same factory floor flexibly: you swap the container module and have a new cleanroom configuration with re-qualification in 2–3 weeks. A conventional cleanroom conversion takes 3–6 months for the same effect. We build CDMO-specific platforms with standard interfaces (power, compressed air, WFI, purified water, nitrogen, extract) – each new container docks at the same supply point. That platform strategy is a concrete competitive advantage for CDMOs.
GMP cleanroom containers for your pharma or biotech project
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