GMP-compliant isolators, filter systems and cleanroom technology for pharma, food and mechanical engineering
Heinbokel & Müller GbR Anlagen- und Apparatebau
Berlin-Weißensee (Gehringstraße 53) · GermanyNew on Amplifa
About HMI-Technik
Heinbokel & Müller GbR (HMI-Technik) was founded in 2001 by Axel Heinbokel and Claus Müller and is based in Berlin-Weißensee. The company develops and manufactures GMP-compliant systems, components and custom special solutions for the pharmaceutical industry, biotechnology, laboratories, cleanroom and high-tech industries as well as the food and mechanical engineering industries. The focus is on containment and process technology: isolators and gloveboxes for sterility testing and aseptic production, extraction filter systems ASF500 and ASF500 WIP up to containment level OEB 5, filter modules for supply air filtration, weighing tables, mixing/dispensing systems and laminar flow workstations. Design follows the EU GMP guideline (Annex 1) and ISPE recommendations with surface qualities of Ra < 0.8 µm; manufacturing is carried out in stainless steel 1.4404/316L with acceptance test certificates per EN 10204-3.1 and FDA-compliant sealing materials. The range of services covers factory and layout planning, manufacturing, installation, maintenance as well as qualification and validation (DQ, IQ, OQ). Filter tests and calibrations are performed by the partner VERIKAL. The 30-person team supports projects from pre-planning through to production start-up.
- Site
- Berlin
- Processes
- Plant and apparatus engineering (GMP-compliant), Planning & engineering, Manufacturing & installation, Maintenance & optimization, Qualification & validation (DQ, IQ, OQ), Factory and layout planning, Isolators and gloveboxes for sterility testing, aseptic production and handling of active, Custom-designed mixing/dispensing systems (mobile or stationary)
- Materials
- Stainless steel 1.4404 / 316L, FDA-compliant sealing materials, HEPA H14 filter technology
- Certificates
- ISO 9001 (prepared for Q3 2026), GMP/GxP-compliant manufacturing, Acceptance test certificates EN 10204-3.1, Qualification & validation (DQ, IQ, OQ)
- Founded
- 2001
- Employees
- 30
- Industries
- Pharmaceutical industry, Biotechnology, Laboratories and research institutions, Cleanroom and high-tech industries, Food industry, Mechanical engineering
- 01
Analysis & factory/layout planning
- 02
Planning & engineering
- 03
Manufacturing
- 04
Installation
- 05
Qualification & validation (DQ, IQ, OQ)
- 06
Maintenance, filter tests & calibration (partner VERIKAL)
Materials & Design
Stainless steel 1.4404 / 316L
Certified material with acceptance test certificates per EN 10204-3.1 for GMP-compliant systems and surface qualities of Ra < 0.8 µm.
FDA-compliant sealing materials
Seals for hygienic design in highly regulated pharmaceutical environments.
HEPA H14 filter technology
Filter class for extraction filter systems and supply air modules per ISO 14644, also with membrane filter stage and WIP function up to OEB 5.
Locations
Berlin-Weißensee
DEPlanning, engineering, manufacturing and installation
- Lot size
- Single systems, custom builds, prototypes, small series
- Materials
- Stainless steel 1.4404/316L, FDA-compliant sealing materials
- Extraction filter system ASF500
- Extraction filter system ASF500 WIP
- Filter module FMV / FMV500
- Filter module Basic FMB
- Weighing table WT / WTA
- Laminar flow workstation
- Glove testing disk AGT / DGT
- Sterility test isolator
Products & Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Plant and apparatus engineering (GMP-compliant)Engineering | Ra < 0.8 µm (surface quality of the | – | – | – | Stainless steel 1.4404/316L |
| Planning & engineeringEngineering | – | – | – | – | – |
| Manufacturing & installationAssembly | – | – | – | – | – |
| Maintenance & optimizationEngineering | – | – | – | – | – |
| Qualification & validation (DQ, IQ, OQ)Testing | – | – | – | – | – |
| Factory and layout planningEngineering | – | – | – | – | – |
| Isolators and gloveboxes for sterility testing, aseptic production and handling of activeAssembly | – | – | – | – | – |
| Custom-designed mixing/dispensing systems (mobile or stationary)Assembly | – | – | – | – | – |
| Weighing tables with and without integrated extractionAssembly | – | – | – | – | – |
| Custom builds and prototypesAssembly | – | – | – | – | – |
| GxP-compliant assemblies and componentsAssembly | – | – | – | – | – |
| High-containment technology (up to OEB 5)Assembly | – | – | – | – | – |
| ATEX systems (explosion-protected system areas)Assembly | – | – | – | – | – |
| Extraction filter system ASF500 (HEPA H14, up to OEB 3/5)Assembly | – | – | – | – | – |
| Extraction filter system ASF500 WIP (Wash-in-Place, membrane filter stage, up to OEB 5)Assembly | – | – | – | – | – |
| Filter module FMV / FMV500 (supply air filtration with fan, safe-change)Assembly | – | – | – | – | – |
| Filter module Basic FMB (passive supply air filtration)Assembly | – | – | – | – | – |
| Sterility test isolatorAssembly | – | – | – | – | – |
| Custom isolator technologyAssembly | – | – | – | – | – |
| Glove portsAssembly | – | – | – | – | – |
| Glove testing disks (AGT, DGT)Assembly | – | – | – | – | – |
| Laminar flow workstationAssembly | – | – | – | – | – |
| Cleanroom technology (ISO 14644)Assembly | – | – | – | – | – |
| Maintenance, filter tests and calibrations (by partner VERIKAL)Testing | – | – | – | – | – |
| Small series press room cladding for tablet pressesAssembly | – | – | – | – | – |
12 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Extraction filter system | HMI-Technik ASF500 | – | – | – | Berlin-Weißensee |
| Extraction filter system with wash-in-place (WIP) | HMI-Technik ASF500 WIP | – | – | – | Berlin-Weißensee |
| Filter module (active, with fan) | HMI-Technik FMV / FMV500 | – | – | – | Berlin-Weißensee |
| Filter module (passive) | HMI-Technik FMB | – | – | – | Berlin-Weißensee |
| Weighing table | HMI-Technik WT | – | – | – | Berlin-Weißensee |
| Weighing table | HMI-Technik WTA | – | – | – | Berlin-Weißensee |
| Weighing table with extraction | HMI-Technik | – | – | – | Berlin-Weißensee |
| Laminar flow workstation | HMI-Technik | – | – | – | Berlin-Weißensee |
| Glove testing disk | HMI-Technik AGT | – | – | – | Berlin-Weißensee |
| Glove testing disk | HMI-Technik DGT | – | – | – | Berlin-Weißensee |
| Isolator for tablet presses | HMI-Technik | – | – | 2006, 2022 | Berlin-Weißensee |
| Sterility test isolator | HMI-Technik | – | – | – | Berlin-Weißensee |
Additional services
Quality & Compliance
Systems are designed in accordance with the EU GMP guideline (Annex 1) and ISPE recommendations, among other things with minimal dead-space design and surface qualities of Ra < 0.8 µm. HMI supports GMP-compliant commissioning with complete DQ, IQ and OQ documentation; filter tests and calibrations are performed by the partner VERIKAL.
| Evidence | Berlin-Weißensee |
|---|---|
| ISO 9001 (prepared for Q3 2026) | |
| GMP/GxP-compliant manufacturing | |
| Acceptance test certificates EN 10204-3.1 | |
| Qualification & validation (DQ, IQ, OQ) |
Chronicle
- 1999
Predecessor projects: conversion of a micronization system
- 2000
Expansion and forklift exchange on a tumble mixer; design and engineering; first employee
- 2001
Founding of HMI-Technik (Heinbokel & Müller GbR) by Axel Heinbokel and Claus Müller
- 2002
Employee no. 5
- 2005
Development of a weighing isolator
- 2006
Planning and delivery of the first isolator for tablet presses
- 2007
Isolator for a granulation mixer
- 2008
Employee no. 15
- 2009
Development and delivery of dosing units
- 2011
Planning of the backend of a tire pyrolysis plant
- 2015
Start of small-series production of press room cladding for tablet presses
- 2017
Employee no. 20
- 2020
Move into a new office
- 2021
Delivery of the 100th machine of the small series press room cladding for tablet presses
- 2022
Delivery of an isolator for tablet presses of a new machine type
- 2025
Employee no. 30; conversion into a GmbH planned for 2026