Sensitive helpers for sensitive processes: Secudur® gases for pharmaceutical applications.

Pharmaceutical gases from Westfalen: with the highest standards of safety and quality.

As invisible helpers, gases have become indispensable in today's pharmaceutical industry. Westfalen's wide range of products offers you exactly the right product for every need. Despite their diversity, gases from Westfalen have one thing in common: you can be 100% sure that they meet the highest standards of quality and safety.

As a pharmaceutical company, we meet all the regulatory requirements of the German Medicines Act and the corresponding EU regulations. Whether you work with general industrial standards or whether you value compliance with internationally defined quality standards, such as GMP conformity, traceability or complete documentation, Secudur® gases from Westfalen meet the highest standards.

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GMP certification.

Products of our Secudur® brand are manufactured exclusively in a GMP-certified factory. Westfalen's plants are subject to regular, strict monitoring by the authorities.

European Pharmacopoeia (Ph.Eur.).

All gases of the Secudur® series comply with the specifications of the European Pharmacopoeia (Ph. Eur.). Certification according to the US and Japanese pharmacopoeias (USP, JP) is also available as an option. These regulations contain clear guidelines on manufacturing and analytical techniques as well as quality assurance and monitoring.

Good Manufacturing Practices (GMP).

Secudur® gases are manufactured in accordance with Good Manufacturing Practice (GMP) in precisely defined and meticulously documented processes. This includes further quality assurance measures that go beyond the requirements of the pharmacopoeias.

Practically, this means, for example:
- Secudur® gases are supplied in containers with residual pressure valves.
- We have a separate range of containers for filling.

Westfalen voluntarily complies with the demanding GMP specifications in order to always guarantee excellent quality with Secudur® gases.

Documentation..

For your documentation, we will gladly confirm the guarantee of GMP conformity as well as compliance with all relevant specifications of relevant pharmacopoeias with a batch certificate on request. You receive test certificates according to your requirements - from batch documentation to specific testing of each container based on DIN EN 10204.

Traceability.

The Secudur® series is integrated into a close-meshed control network. Analogous to medicinal products, traceability is ensured. The movements of each individual Secudur® container are recorded and fully documented.

Our pharmaceutical gases: standards and mixtures for a wide range of applications.

For the wide range of applications in the pharmaceutical industry, Westfalen offers you a product range under the Secudur® brand that fits your requirements exactly:

Our Secudur® range includes the following gases and gas mixtures: nitrogen, carbon dioxide, oxygen, argon, helium, synthetic air, C5 O95 (a mixture of 5% carbon dioxide and 95% oxygen).

Under the collective term Secudur®-Mix, we also provide you with numerous gas mixtures in pharmaceutical quality to meet your requirements. You can have our pharmaceutical gases put together in almost any combination to create your individual mixture. Production is carried out in accordance with GMP.

Typical applications: This is how our invisible helpers work in the pharmaceutical industry.

Pharmaceutical gases have an excipient status and may therefore not be used on humans. However, they are very useful for the sensitive processes in pharmaceutical production - for example in the following tasks:

Inerting.

Both during packaging and storage, inerting with Secudur® gases is an important part of quality assurance. The exclusion of atmospheric oxygen and moisture rules out undesirable interactions with the pharmaceutical substance.

Cooling.

Cryogenic liquefied gas such as Secudur® N is an excellent, environmentally friendly and economical alternative to mechanical cooling with halogenated hydrocarbons. Many pharmaceutical manufacturing processes can be optimised with Secudur® cryogenic gases, for example grinding, crushing, mixing, freezing or freeze-drying. For cryogenic preservation during storage and transport, Secudur® N also enables precise temperature control down to -196 °C.

Gassing of cell cultures.

The optimum pH value of 7.2 for the growth of many cells must remain as stable as possible. However, cells permanently acidify the nutrient medium with metabolic end products during growth. The constant supply of Secudur® C into the brood chamber stabilises the pH value.

Fermentation.

Fermenters cultivate microorganisms, cells or small plants under the most ideal conditions possible to generate high product yields. Secudur® gases support the biotechnological processes to optimise the growth factors.

Pharma technology from Westfalen: Qualified advice on accessories and supply technology for the pharmaceutical industry.

With its "Pharma Technology" division, Westfalen offers you comprehensive services that go far beyond the supply of Secudur® pharmaceutical gases.
We provide qualified advice on the wide range of supply options for pharmaceutical products. This includes, for example, the selection of suitable cylinder pressure reducers or a quotation for the installation of tank systems with a capacity of several 10,000 litres and the associated cryogenic or gaseous supply by Westfalen.
Making the right choice requires a lot of knowledge and experience: often a whole range of regulations has to be taken into account. The Food and Drug Administration (FDA), for example, is responsible for the approval of medicines in the USA. This means that their regulations apply to all companies that market a drug in the USA. The FDA is responsible for approvals for pharmaceutical manufacturing operations, but also for imposing suspensions. Regulations on basic conditions required for approval, but also on defined specifications, e.g. regarding ingredients in elastomers for sealing purposes, are contained in the Code of Federal Regulations Title 21 Part 177.2600.
A central component of another set of regulations, the EU GMP Guide, is the qualification of equipment such as machines, devices and premises. Qualification is the demonstration that equipment works properly and actually leads to the expected results. Technical supply systems that provide pharmaceutical nitrogen, for example, are also described by a qualification.

Qualification processes in more detail: Design Qualification and Installation Qualification for the pharmaceutical industry.

Design Qualification (DQ).

When it comes to pharmaceutical gases, a specification resulting from the design qualification describes in detail the requirements for Westfalen.
A typical requirement, for example, is the redundancy of a tank system. By installing two cryogenic storage tanks from which samples are taken alternately, the operator has the option of taking samples, analysing them and releasing them. Only after this release may the product be taken from the container in standby.

Another content of the specifications can be the requirement for continuous monitoring of the liquid nitrogen stock.

The transmission of fill levels in tanks and cylinders by Westfalen guarantees the operator constant availability of the gases.
In addition, this can automate ordering procedures for the user.

Requirements for the spatial design of a plant must also be met. As a planning tool, Westfalen offers its customers a 3D CAD design. If required, the data models created can be exchanged with project partners such as architects, other media suppliers and plant constructors.

Installation Qualification (IQ).

The installation procedure and all steps required for commissioning are described in detail. A complete, traceable documentation of material certificates, starting with the inner container of the cryogenic tank, the fittings, sealing materials and piping up to the defined interface, for example a cryopreservation by the customer, is handed over to the pharmaceutical manufacturing company. Thus, this qualification process ensures that the delivered equipment meets the specifications of the Design Qualification (DQ) for the pharmaceutical industry.

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Sensible Helfer für sensible Prozesse
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Produktlinie Secudur® Stellungnahme
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Product line Secudur® Statement
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