Contract sterilization of medical and pharmaceutical products with ethylene oxide including validation, laboratory analytics and quarantine storage.
HA2 Medizintechnik GmbH
Halberstadt (Tschaikowskistraße 2) · Halberstadt (Am Bahndamm 11) · Halberstadt (Wredestraße 3)New on Amplifa
About HA2
HA2 Medizintechnik GmbH is a service provider specialized in the sterilization of medical devices and pharmaceutical products, headquartered in Halberstadt, Saxony-Anhalt. Its core service is gas sterilization with ethylene oxide (EO), a material-friendly process that achieves a sterilizing effect even at low temperatures and is particularly suitable for heat-sensitive products, complex geometries and different material combinations. The range of services includes, in addition to validated routine sterilization, validation of sterilization processes, microbiological and chemical in-process and final controls in its own laboratory, as well as consulting on customer-specific sterilization solutions. The goods are delivered fully packaged on Euro pallets; the process comprises preconditioning, EO fumigation, postconditioning, laboratory testing and quarantine storage. With more than ten sterilization chambers (capacities of 4 to 20 pallets), three plants within a radius of five kilometers and a quarantine warehouse with 7,400 pallet spaces, 175,000 pallets are sterilized annually in 24/7 four-shift operation. Its central location in Germany enables short transport routes to customers throughout Europe.
- Site
- Halberstadt
- Processes
- EO sterilization (sterilization with ethylene oxide), Validation of sterilization processes, Microbiological and chemical in-process and final controls, Laboratory analytics (evaluation of biological indicators in the in-house laboratory), Consulting and customer-specific sterilization solutions, EO sterilization (ethylene oxide gas sterilization), Microbiological and chemical in-process and final controls (own laboratory), Quarantine warehouse (7,400 pallet spaces)
- Materials
- Plastics, Ethylene oxide gas sterilization
- Certificates
- EN ISO 13485, EN ISO 11135, FDA Establishment Registration & Device Listing, ISO 50001:2018, BG21300380, BG21301032, BG21301178
- Founded
- 2000
- Industries
- Medical technology, Pharmaceutical industry
- 01
Delivery of fully packaged goods on Euro pallets
- 02
Loading with color indicator and biological indicator per pallet
- 03
Preconditioning (temperature adjustment and humidification)
- 04
EO sterilization according to a validated process
- 05
Gas evacuation and disposal via the disposal system
- 06
Postconditioning (temperature adjustment, high air exchange rate)
- 07
Evaluation of the biological indicators in the in-house laboratory
- 08
Quarantine storage until release
- 09
Outbound goods with live tracking
Materials & Processes
Ethylene oxide gas sterilization
Material-friendly gas sterilization at low temperatures, suitable for heat-sensitive medical and pharmaceutical products as well as plastics.
Plastics
EO sterilization is particularly suitable for plastics and complex material combinations.
Locations
Halberstadt – Tschaikowskistraße 2
DEContract sterilization with ethylene oxide incl. microbiological/chemical controls
- Lot size
- Batches of 4 to 20 pallets per chamber
- Materials
- Medical devices, pharmaceutical products, plastics
- More than 10 EO sterilization chambers
- Preconditioning chambers
- Postconditioning chambers
Halberstadt – Am Bahndamm 11
DEContract sterilization with ethylene oxide incl. microbiological/chemical controls; high-bay warehouse
- EO sterilization chambers
- Disposal system for ethylene oxide
- High-bay warehouse with 7,400 pallet spaces
- In-house laboratory for biological indicator evaluation
Halberstadt – Wredestraße 3
DEContract sterilization with ethylene oxide (new building 2018–2022)
- EO sterilization chambers
- Disposal system for ethylene oxide
Components
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| EO sterilization (sterilization with ethylene oxide)Testing | – | – | – | – | Medical devices, pharmaceutical products, plastics |
| Validation of sterilization processesTesting | – | – | – | – | Medical devices |
| Microbiological and chemical in-process and final controlsTesting | – | – | – | – | – |
| Laboratory analytics (evaluation of biological indicators in the in-house laboratory)Testing | – | – | – | – | – |
| Consulting and customer-specific sterilization solutionsEngineering | – | – | – | – | – |
6 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| EO sterilization chamber | – | more than | Capacities of 4 to 20 pallets | – | Halberstadt |
| Preconditioning chamber | – | – | – | – | Halberstadt |
| Postconditioning chamber | – | – | – | – | Halberstadt |
| Disposal system for ethylene oxide | – | – | – | – | Halberstadt |
| Laboratory (in-house laboratory for biological indicator evaluation) | – | – | – | – | Halberstadt |
| High-bay warehouse | – | 1 | 7,400 pallet spaces | 2003 | Halberstadt |
Additional services
Quality & Certifications
HA2 works with validated processes, automated process control and continuous monitoring of all relevant parameters. An in-house laboratory performs microbiological and chemical in-process and final controls; internal and external audits by notified bodies and customers complement the quality management system.
| Evidence | Halberstadt |
|---|---|
| EN ISO 13485 | |
| EN ISO 11135 | |
| ISO 50001:2018 | |
| FDA Establishment Registration & Device Listing |
History
- 2000
Founding of HA2
- 2002
New construction of the Am Bahndamm plant
- 2003
Construction of a new high-bay warehouse
- 2013
Sterilization of more than 100,000 pallets per year
- 2016
Certification of an energy management system
- 2018
New construction of the Wredestraße plant
- 2020
Commissioning of further sections of the Wredestraße plant
- 2021
Capacity increase to 175,000 pallets per year
- 2022
Completion of the Wredestraße plant