Aseptic filling machines and contract filling using the Blow-Fill-Seal technology invented by Rommelag.
Rommelag SE & Co. KG
Sulzbach-Laufen · Abtsgmünd-Untergröningen · Buchs · Reitnau · Zell LU · Columbia (SC) · ShanghaiNew on Amplifa
Rommelag: Inventor of Blow-Fill-Seal Technology
Rommelag is the inventor of Blow-Fill-Seal technology (BFS) and manufactures the bottelpack aseptic systems at its headquarters in Sulzbach-Laufen and in Reitnau (CH), which form, fill and hermetically seal liquid and semi-solid products in a single closed process. The machines achieve output rates of up to 37,500 containers per hour at fill volumes of 0.1 to 1,000 ml for ampoules and bottles. As an experienced contract filler (CDMO), the group produces more than two million BFS containers daily for customers from the pharmaceutical, healthcare, cosmetics and chemical sectors. Recyclable pharmaceutical-grade polymer granules, primarily LDPE and PP, are used as monomaterials. The group, with more than 2,300 employees, also offers product development, qualification and validation, factory planning, digitalization (Rommelag Pharma Platform), modernizations, used machines and after-sales services. Locations are situated in Germany, Switzerland, the USA and China.
- Site
- Sulzbach-Laufen
- Processes
- Blow-Fill-Seal (BFS) aseptic filling, Contract filling (CDMO) of liquid and semi-solid products, Product development and optimization for BFS technology, Qualification & validation (Rommelag Pharma Service), Factory planning & production optimization, Digitalization / Rommelag Pharma Platform (RPP), After-sales: maintenance, inspection, remote maintenance, spare parts, repairs, Modernization, retrofit and upgrades of bottelpack machines
- Materials
- LDPE, PP (polypropylene), PE films, Polymer granules (pharmaceutical grade, monomaterial), Blow-Fill-Seal process, LDPE (low-density polyethylene), Pharmaceutical-grade polymer granules, cool-BFS process
- Certificates
- ISO 9001:2015, ISO 13485:2016, ISO 50001:2018, ISO 15378, ISO 9001, ISO 13485, ISO 50001
- Founded
- 1952 (foun
- Employees
- >2300
- Industries
- Pharmaceuticals, Healthcare, Cosmetics, Chemicals
- 01
Engineering and machine construction (bottelpack)
- 02
Extrusion of the polymer granules into a parison
- 03
Container forming (Blow)
- 04
Aseptic filling (Fill)
- 05
Hermetic sealing (Seal)
- 06
Qualification, validation and after-sales
Materials and Processes
Blow-Fill-Seal process
Fully automated aseptic process in which containers are formed from sterile polymer granules, filled immediately and hermetically sealed.
LDPE (low-density polyethylene)
Soft, recyclable monomaterial for sterile ampoules, e.g. for eye drops and injection solutions.
PP (polypropylene)
For injectable ampoules with Luer connector and products that are sensitive to heat, light or oxygen.
Pharmaceutical-grade polymer granules
Recyclable monomaterial whose production waste is regranulated and reused in the BFS process.
PE films
The company's historical origin: extrusion, printing and converting of PE films.
cool-BFS process
Enables the safe contract filling of temperature-sensitive and sensitive products since 2012.
BFS container design
Flexible container geometries with twist-off cap, dropper, Luer connector, hanger or grip recess.
Locations
Sulzbach-Laufen
DEHeadquarters, machine construction (Rommelag Engineering), CDMO (Holopack), training center
- Materials
- LDPE, PP, polymer granules
- bottelpack bp 460-15
- bottelpack bp 460-18
- bottelpack bp 460-20
- bottelpack bp 530
- bottelpack bp 550
- bottelpack bp 321
- bottelpack bp 360
- bottelpack bp 364
- bottelpack bp 730
Abtsgmünd-Untergröningen
DECDMO (Rommelag CDMO GmbH)
- Materials
- LDPE, PP, polymer granules
- bottelpack machines
Reitnau
CHMachine construction (Rommelag Engineering Switzerland AG, formerly Maroplastic)
- bottelpack machines
Zell LU
CHCDMO (Rommelag CDMO Switzerland AG, formerly Maropack), BSL-2 production
- Materials
- LDPE, PP, polymer granules
- bottelpack machines
Buchs
CHSales and service (Rommelag Switzerland AG)
Columbia (South Carolina)
USCDMO (Holopack International, since 1995)
- Materials
- LDPE, PP
- bottelpack machines
Shanghai
CNSales and service (Rommelag Trading, since 2007)
BFS Containers
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Blow-Fill-Seal (BFS) aseptic fillingPlastics | – | – | – | – | LDPE, PP, polymer granules |
| Contract filling (CDMO) of liquid and semi-solid productsPlastics | – | – | – | – | LDPE, PP |
| Product development and optimization for BFS technologyEngineering | – | – | – | – | – |
| Qualification & validation (Rommelag Pharma Service)Testing | – | – | – | – | – |
| Factory planning & production optimizationEngineering | – | – | – | – | – |
| Digitalization / Rommelag Pharma Platform (RPP)Engineering | – | – | – | – | – |
| After-sales: maintenance, inspection, remote maintenance, spare parts, repairsAssembly | – | – | – | – | – |
| Modernization, retrofit and upgrades of bottelpack machinesAssembly | – | – | – | – | – |
| Sale of refurbished bottelpack used machinesAssembly | – | – | – | – | – |
| Film extrusion (PE films, historical origin)Plastics | – | – | – | – | PE |
11 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| bottelpack BFS filling machine for ampoules | Rommelag/Kocher-Plastik bp 460-15 | – | Fill volume 0.2–10 ml, ampoule length up to 92 mm, up to 31,000 pcs/h | – | – |
| bottelpack BFS filling machine for ampoules | Rommelag/Kocher-Plastik bp 460-18 | – | Fill volume 0.2–10 ml, ampoule length up to 68 mm, up to 33,000 pcs/h | – | – |
| bottelpack BFS filling machine for ampoules | Rommelag/Kocher-Plastik bp 460-20 | – | Fill volume 0.2–5 ml, ampoule length up to 68 mm, up to 37,500 pcs/h | – | – |
| bottelpack BFS filling machine for ampoules | Rommelag/Kocher-Plastik bp 530 | – | Fill volume 0.1–20 ml, ampoule length up to 130 mm, up to 12,960 pcs/h | – | – |
| bottelpack BFS filling machine for ampoules | Rommelag/Kocher-Plastik bp 550 | – | Fill volume 0.1–20 ml, ampoule length up to 130 mm, up to 21,600 pcs/h | – | – |
| bottelpack BFS filling machine for bottles | Rommelag/Kocher-Plastik bp 321 | – | Fill volume 100–1,000 ml, bottles up to 303 mm, up to 2,500 pcs/h | – | – |
| bottelpack BFS filling machine for bottles | Rommelag/Kocher-Plastik bp 360 | – | Fill volume 100–1,000 ml, bottles up to 303 mm, up to 5,000 pcs/h | – | – |
| bottelpack BFS filling machine for bottles | Rommelag/Kocher-Plastik bp 364 | – | Fill volume 100–1,000 ml, bottles up to 303 mm, up to 9,200 pcs/h | – | – |
| bottelpack BFS filling machine for bottles | Rommelag/Kocher-Plastik bp 730 | – | Fill volume 100–1,000 ml, bottles up to 303 mm, up to 3,200 pcs/h | – | – |
| bottelpack BFS filling machine for bottles (used machine) | Rommelag/Kocher-Plastik bp 320 | – | Fill volume 100–1,000 ml, up to 1,200 pcs/h | 1994 | – |
| bottelpack BFS filling machine for bottles (used machine) | Rommelag/Kocher-Plastik bp 321 | 3 | Fill volume 100–1,500 ml, up to 800 pcs/h | 1994, 2001 | – |
Additional services
Quality and Certifications
The group operates certified quality management systems in accordance with ISO 9001 and ISO 13485, supplemented by ISO 50001 (energy management) and ISO 15378 (pharmaceutical packaging). The bottelpack machines meet the requirements of Annex 1 of the EU GMP Guide as well as those of the EMA, FDA, Anvisa and Abrasp authorities.
| Evidence | Sulzbach-Laufen | Abtsgmünd-Untergröningen | Reitnau | Zell LU |
|---|---|---|---|---|
| ISO 9001 | ||||
| ISO 13485 | ||||
| ISO 50001 | ||||
| ISO 15378 |
Company History
- 1952
Gerhard Hansen founds Thermo-Pack for the extrusion, printing and converting of PE films.
- 1960
Gerhard Hansen invents Blow-Fill-Seal technology and builds the first bottelpack prototype.
- 1964
Kocher-Plastik Maschinenbau GmbH goes into operation in Sulzbach-Laufen; Rommelag AG takes over sales in Buchs (CH).
- 1967
Founding of Rommelag Kunststoff-Maschinen Vertriebsgesellschaft mbH in Waiblingen.
- 1968
Starting signal for Maroplastic in Reitnau (CH) for machine production in Switzerland.
- 1975
Founding of Holopack Verpackungstechnik in Sulzbach-Laufen – the beginning of contract filling.
- 1980
Maropack AG is established as a contract filling plant in Zell (CH).
- 1981
Second Holopack plant in Abtsgmünd-Untergröningen under the leadership of Bernd Hansen.
- 1983
Founding of Rommelag USA in Colorado for sales and service.
- 1985
Dipl.-Ing. Bernd Hansen takes over management as managing partner.
- 1995
Founding of Holopack International in Columbia (South Carolina) for contract filling in accordance with FDA guidelines.
- 1996
Introduction of the quality management system in accordance with ISO 9001.
- 2001
Installation of the fiftieth bottelpack machine at Rommelag CMO.
- 2003
The thousandth bottelpack machine goes into operation; a representative office is established in Shanghai.
- 2007
Founding of Rommelag Trading in Shanghai to strengthen sales in Asia.
- 2010
Inauguration of the BSL-2 building at Maropack Zell – the world's first BFS production with Bio Safety Level 2.
- 2011
Commissioning of the new pharmaceutical building with suite concept at Holopack Sulzbach-Laufen.
- 2012
Introduction of the cool-BFS process for temperature-sensitive products.
- 2013
Inauguration of the bottelpack training center in Sulzbach-Laufen.