Gases for the pharmaceutical industry
Gases for the pharmaceutical industry PHARMALINE – Our Range of Gases for the Pharmaceutical Industry.
At Messer, we have grouped two categories of gases under the product name “Pharmaline”. These are gases used by our customers:
- in manufacture of an intermediate, an active substance or a medicinal product (including, but not limited to process aids); or
- as constituents of a medicinal product other than the active substance and the packaging material (excipients).
The Pharmaline gases are:
- Pharmaline A: Argon (Ar), could be used for inertisation
- Pharmaline C: Carbon dioxide (CO2) for various applications, including the production of drugs in powder form
- Pharmaline N: Nitrogen (N2), could be used for packaging under inert gas atmosphere
In addition to our Pharmaline gases, we provide the necessary armatures or gas supply facilities for the pharmaceutical industry. In case of high demand, we offer on-site gas supply production.
Unlike medicinal products and active substances, there are no binding GMP guidelines for Pharmaline gases. However, we understand well which EU pharmaceutical legislation applies to our customers, i.e., manufacturers of active substances as well as manufacturers and marketing authorisation holders of medicinal products. Compliance with the underlying regulations is essential for the execution of contracts with our customers. Thus, we operate a quality management system that takes the special characteristics of Pharmaline gases into account, reduces the amount of testing that has to be performed by the user and makes it easier for them to comply with the obligations defined in EU Directive 2001/83 and the GMP guidelines.
What Pharmaline offers:
- Quality management based on ISO 9001
- Messer strictly aligns the Pharmaline production with ISO 9001. ISO 9001 is defined as the international standard that specifies requirements for a quality management system (QMS). Messer follows this standard to consistently provide products and services that meet customer and regulatory requirements.
- European Pharmacopoeia Specifications
- Our Pharmaline gases reliably fulfil the relevant specifications of the European Pharmacopoeia.
- Risk-based approach
- The design, planning and implementation of our gas supply, production and control processes are based on risk analysis to ensure that the correct quality assurance measures are taken.
- Batch production with full traceability
- Each cylinder and cylinder bundle within a batch is supplied with a Certificate of Conformity. Bulk gases that are delivered by tank truck are accompanied by a Certificate of Analysis. Records of the entire manufacturing process facilitate full traceability of all Pharmaline products.
- Certificate of Analysis
- Messer’s Certificate of Analysis shows that our liquid gases conform to established specifications. Therefore, our gases used as processing aids do not need to be tested by users.
- Tamper-proof seals
- Cylinders and bundles in which Pharmaline gases are delivered have a tamper-evident seal so the user can immediately check that the cylinder in question has remained intact and unopened since it was filled.
- Uniform quality
- All our Pharmaline manufacturing sites use the same quality management system. If certain process steps are outsourced to external partners, this is done on the basis of clear contractual arrangements.
- Continuous control and optimisation of our quality management system
- Our quality management is subject to continuous monitoring and improvement. To this end, we regularly discuss our objectives, efficiency, effectiveness and implementation of our quality management systems.
Feel free to contact us!
If you have any questions regarding Pharmaline or should you wish to consult with our application experts in person, please do not hesitate to contact us.