Machines and complete lines for the aseptic primary packaging of parenteral medications
ROTA Verpackungstechnik GmbH & Co. KG
79664 Wehr (company headquarters, production, assembly)New on Amplifa
Family-owned machine building for sterile pharmaceutical packaging
ROTA Verpackungstechnik is a family-owned machinery manufacturer founded in 1909 and headquartered in Wehr in south-west Germany. The company develops and manufactures machines and systems for washing, sterilizing, filling, closing, inspecting and labeling ampoules, vials, syringes and ready-to-use objects for the aseptic primary packaging of parenteral medications. The product portfolio comprises individual machines, complete fill-finish lines, and solutions for small batches and nest processing. Thanks to a high in-house production depth with its own design engineering and complete machine building, tailored solutions are created for the pharmaceutical and biotech industries. The offering is complemented by format and spare parts, maintenance and worldwide service. The machines meet GMP requirements as well as the specifications of the FDA, EMA and other regulatory authorities.
- Site
- Wehr
- Processes
- Washing & cleaning (machines for ampoules, vials, ready-to-use objects), Sterilizing, Filling, Closing, Inspection, Labeling, Complete lines (fill-finish), Small batches
- Certificates
- ISO 9001:2015, GMP / FDA / EMA
- Founded
- 1909
- Employees
- more than 100
- Industries
- Pharmaceutical industry, Biotechnology
- 01
Design engineering (in-house)
- 02
Manufacture of individual parts (almost entirely in Germany)
- 03
Assembly of machines and lines
- 04
Commissioning
- 05
Inspection
- 06
Spare parts, format parts, maintenance and service
Location
Wehr
DECompany headquarters, production, assembly
- Large assembly hall (completed in 2020)
Applications and Objects
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Washing & cleaning (machines for ampoules, vials, ready-to-use objects)Engineering | – | – | – | – | – |
| SterilizingEngineering | – | – | – | – | – |
| FillingEngineering | – | – | – | – | – |
| ClosingEngineering | – | – | – | – | – |
| InspectionInspection | – | – | – | – | – |
| LabelingEngineering | – | – | – | – | – |
| Complete lines (fill-finish)Engineering | – | – | – | – | – |
| Small batchesEngineering | – | – | – | – | – |
| Manufacture of machines for the aseptic primary packaging of parenteral medications (ampoules,Assembly | – | – | – | – | – |
Additional services
Certified Quality
ROTA is certified to ISO 9001:2015; implementation of the standard is regularly audited by the certification body LRQA. In addition, the machines meet GMP requirements as well as the specifications of the FDA, EMA and other regulatory authorities.
| Evidence | Wehr |
|---|---|
| ISO 9001:2015 | |
| GMP / FDA / EMA |
Company History
- 1909
Founding of ROTA as a family business; development of a first simple ampoule filling and closing machine
- 1991
Start of cooperation with Yokogawa; the flowmeter division is gradually integrated into the Japanese Yokogawa Group by 1995
- 1995
Re-establishment as ROTA Verpackungstechnik with nearly 30 employees
- 1998
Construction of the new company headquarters in Wehr
- 2020
Completion of the large assembly hall