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Sensitive Aids for Sensitive Processes: Secudur®. GMP, Ph. Eur., etc.

You decide – what requirements must a Just right for your QM system: fulfil to be used for pharmaceutical products Secudur® pharmaceutical . manufacture? Are general industrial standards What standards are defined in your Quality sufficient? Or do you look for compliance with Management System? Westfalen’s Secudur® internationally defined quality standards, GMP range has been specially developed to meet conformity, traceability, full documentation …? the requirements of the pharmaceutical industry. Secudur® gases meet the highest demands:

European Pharmacopoeia (Ph. Eur.) All gases in the Secudur® range meet the requirements of the European Pharmacopoeia (Ph. Eur.). Certifications to the US Pharma- Secudur® N () copoeia (USP) and Japanese Pharmacopoeia can be used in a wide (JP) are an additional option. range of applications, for example freeze-drying These regulations contain clear guidelines of parenterals. on manufacturing and analytical methods and also on quality assurance and quality monitoring. Secudur® pharmaceutical gases comply with these regulations.

Good Manufacturing Practice (GMP) Secudur® gases are manufactured in ac- cordance with Good Manufacturing Practice (GMP) in precisely defined and documented processes. They are subject to further quality assurance measures that exceed the require- There is a raft of condi- ments of the pharmacopoeias. In practice, this tions to be met before means for example that Secudur® gases are a medicinal product can supplied in containers with residual pressure “come off the conveyor valves. For filling, we have a separate container belt”. Westfalen’s com- pool. All process steps are fully documented. prehensive experience and know-how provides support for the gases you use.

Quality comparison: Westfalen’s Secudur® N vs. Ph. Eur., USP and JP “Nitrogen”.

Content/impurities N2 CO2 CO H2O O2 Unit vol. % vol. ppm vol. ppm vol. ppm vol. ppm Secudur® N > 99.999 ≤ 5 ≤ 5 ≤ 5 ≤ 3 Ph. Eur. “Nitrogen” ≥ 99.5 ≤ 300 ≤ 5 ≤ 67 ≤ 50 Ph. Eur. test method GC IR IR Electrochem. Electrochem. cell cell USP “Nitrogen” ≥ 99.0 – ≤ 10 – ≤ 10,000 USP test method GC – Test tube – GC JP “Nitrogen” ≥ 99.5 Complies – – – JP test method GC Wet chem. – – – analysis

2 19.0/13 Westfalen voluntarily meets the stringent Traceability conditions of the Ph. Eur. and GMP to ensure The Secudur® range is subject to a closely- consistently excellent quality in Secudur® integrated control system, ensuring similar pharmaceutical gases. Would you expect traceability to that of medicinal products. anything less? The movements of each individual Secudur® container are recorded and documented.

Following initial filling, tank installations for larger users receive separate approval for Secudur® pharmaceutical gases.

Secudur® gases are fundamental to pharmaceutical manufacturing processes. The excellent quality of these “invisible aids” is fully documented.

19.0/13 3 Just right for your applications. Inerting Westfalen offers you perfectly matched The exclusion of atmospheric and Secudur® gas for a wide range of pharma- moisture prevents adverse interactions with ceuticals industry applications: the pharmaceutical substance. Inerting with Secudur® gases is a key factor in quality • Secudur® Ar () assurance in both packaging and storage. • Secudur® C () • Secudur® C5 O95 (mixture of 5 % carbon Cooling dioxide and 95 % oxygen, previously Cryogenic pharmaceutical gases such as known as “Carbogen 5”) Secudur® N or Secudur® C are an excellent • Secudur® He () environmentally safe and economical • Secudur® N (nitrogen) alternative to mechanical cooling using • Secudur® O (oxygen) halogenated hydrocarbons. A number of • Secudur® SL (synthetic air) pharmaceutical manufacturing processes can be optimised using cryogenic Secudur® We also offer a number of pharmaceutical gases, including grinding, crushing, mixing, gas mixtures under the collective name freezing or freeze-drying. In low-tempera- Secudur® Mix; you can have virtually any ture preservation during storage and combination of gases in the Secudur® transport, Secudur® N is also instrumental range in “your” mixture, manufactured in in ensuring precise temperature control line with GMP. down to minus 196 degrees Celsius.

Even though Secudur® gases are not medicinal products – they are excipients, so consequently cannot be used for human applications – they are extremely useful in pharmaceutical production. Examples include:

Cylinders for Westfalen’s Secudur® gases, in this case Secudur® N (nitrogen), can be identified by the following features: grey cylinder body, shoulder colour as specified by DIN EN 1089-3, chrome-plated valve, integrity seal with batch number and expiry date, neck band with Aesculapian staff, plus barcode for batch traceability. Fitting a residual pressure valve with a non-return mechanism prevents total discharge and potential contamination due to backflow.

19.0/13 4 Aeration of cell cultures Fermentation The optimum pH of 7.2 for the growth of Fermenters cultivate microorganisms, a large number of cells must remain as cells or small plants under the most ideal stable as possible. Cells constantly acidify conditions possible in order to generate the nutrient medium during growth with high product yield. Secudur® gases support metabolic end products; a constant supply the biotechnological processes to optimise of Secudur® C in the incubator stabilises the growth factors. the pH.

Documentation: in black and white.

In essence, when you choose gases from the Secudur® range you are guar- anteed GMP conformity and compliance with all relevant requirements of the appropriate pharmacopoeias. Upon request we can verify this for your documentation by providing individual certificates per delivery.

You will receive test certificates to your requirements, from batch docu- mentation through to the specific testing of each container according to DIN EN 10204.

Down to the last detail: we will be happy to advise you on suitable distribution and discharge systems for Secudur® pharmaceutical gases.

19.0/13 5 Just right for your needs. Westfalen operates a separate container pool for pharmaceutical gases in the Secudur® range. These containers undergo rigorous controls to ensure there is no risk of contami- nation. Low and medium demand is met by gas cylinders in 2, 10, 13 or 50 litre sizes or by bundles totalling 600 litres nominal volume.

For bulk consumers, we provide stationary tank installations together with a compre- Convenience: automatic hensive services package including: level monitoring with • installation of Datafer®, our remote data Westfalen’s Datafer® transmission system for level monitoring system. • analysis of the tank contents following initial delivery, and approval for Secudur® pharmaceutical gases with corresponding documentation • optional dual tank installation for batch consumption based on your individual approval strategy

Just the right match. Please contact us for further details on the many options offered by Westfalen’s Cryopreservation with Secudur® range. Secudur® N: the extremely low temperature of We can help you select your “invisible nitrogen significantly aids” and advise you on the best supply lowers the reaction rates option for your requirements, so that of chemical and biochem- ultimately you can be certain everything is ical processes. Because right for your needs. Secudur® N is also non- toxic, taste-neutral and chemically inert, it offers ideal conditions for the preservation of living cells and biological tissue.

Foto: Helixor/ralf knöringer fotografie Foto: Helixor/ralf knöringer fotografie Foto: Helixor/ralf Secudur® pharmaceutical gases protect medicinal products from contamination by atmospheric oxygen or moisture - here, Secudur® Ar (argon) used in filling ampoules.

19.0/13 6 At a glance: Secudur® pharmaceutical gases. Name Gas Delivery mode* Content** Common applications Secudur® N Nitrogen 10 l 1.6 m3 - For manufacturing pharmaceutical 50 l 9.6 m3 active ingredients (e.g. rinsing, injection) 12 x 50 l bundles 115.2 m3 - As a protective gas for inerting Liquid in a mobile or As required - For packaging pharmaceutical stationary tank products In 300 bar technology: - For cold grinding 50 l 13.2 m3 - In cryopreservation 12 x 50 l bundles 158.4 m3 Secudur® C Carbon dioxide *** 2 l 1.5 kg - For aerating cell cultures - For pH control 13 l 10.0 kg - For manufacturing pharmaceutical 50 l 37.5 kg active ingredients 12 x 50 l bundles 450.0 kg Secudur® O Oxygen 50 l 10.6 m3 - In cell biology - For fermentation in fermenters 12 x 50 l bundles 127.2 m3 (bioreactors)

Secudur® He Helium 50 l 9.1 m3 - For rinsing 12 x 50 l bundles 109.2 m3 - As a protective gas for inerting Secudur® Ar Argon 50 l 10.7 m3 - As a protective gas for inerting 12 x 50 l bundles 128.4 m3 - For packaging pharmaceutical products - As a protective gas for the storage of sensitive products Secudur® SL Synthetic air 50 l 10.0 m3 - As a protective gas for inerting (21.75 vol. % oxygen, 12 x 50 l bundles 120.0 m3 - For packaging pharmaceutical balance nitrogen) products Secudur® Carbogen 5 10 l 2.2 m3 - For supplying oxygen to tissue C5 O95 (5 vol. % carbon dioxide, samples and microorganism 3 balance oxygen) 50 l 11.0 m cultures 12 x 50 l bundles 132.0 m3 - For creating a specific atmosphere

Secudur® Individual mixture of 2 l 0.4 m3 Individual applications Mix Secudur® gases, upon 10 l 2.0 m3 request 50 l 10.0 m3 12 x 50 l bundles 120.0 m3 * Pressure at 15 °C: 200 bar ** Content at 15 °C and 1 bar, unless otherwise stated *** Vapour pressure at 15 °C: 50.9 bar

Secudur® - safety you can rely on.

The trade name Secudur® is derived from the Latin - “securitas” (safety) plus “durabilis” (lasting), together giving “lasting safety”. This is a promise for customers using the Secudur® range.

19.0/13 7 Technical Gases I I

At a glance: Secudur® pharmaceutical gases. Name Gas Delivery mode* Content** Common applications Secudur® N Nitrogen 10 l 1.6 m3 - For manufacturing pharmaceutical 50 l 9.6 m3 active ingredients (e.g. rinsing, injection) 12 x 50 l bundles 115.2 m3 - As a protective gas for inerting Liquid in a mobile or As required - For packaging pharmaceutical stationary tank products In 300 bar technology: - For cold grinding 50 l 13.2 m3 - In cryopreservation 12 x 50 l bundles 158.4 m3 Secudur® C Carbon dioxide *** 2 l 1.5 kg - For aerating cell cultures - For pH control 13 l 10.0 kg - For manufacturing pharmaceutical 50 l 37.5 kg active ingredients 12 x 50 l bundles 450.0 kg Secudur® O Oxygen 50 l 10.6 m3 - In cell biology - For fermentation in fermenters 12 x 50 l bundles 127.2 m3 (bioreactors)

Secudur® He Helium 50 l 9.1 m3 - For rinsing 12 x 50 l bundles 109.2 m3 - As a protective gas for inerting Secudur® Ar Argon 50 l 10.7 m3 - As a protective gas for inerting 12 x 50 l bundles 128.4 m3 - For packaging pharmaceutical Westfalen GmbH Westfalen BVBA-SPRL Westfalen Gas s.r.o. Westfalen S.à.r.l. products Aumühlweg 21/TOP 323 Watermolenstraat 11 Masarykova 162 Parc d‘Activités Belle Fontaine - As a protective gas for the storage 2544 Leobersdorf 9320 Aalst/Alost 344 01 Domažlice 57780 Rosselange of sensitive products Austria Czechia France

3 Phone +43 (0) 22 56/6 36 30 Phone +32 (0)53-64.10.70 Phone +420 379 420 042 Phone +33 (0)3.87.50.10.40 Secudur® SL Synthetic air 50 l 10.0 m - As a protective gas for inerting Fax +43 (0) 22 56/6 36 30-3 30 Fax +32 (0)53-67.39.07 Fax +420 379 420 032 Fax +33 (0)3.87.50.10.41 3 (21.75 vol. % oxygen, 12 x 50 l bundles 120.0 m - For packaging pharmaceutical www.westfalen.at www.westfalen.be www.westfalen.cz www.westfalen-france.fr balance nitrogen) products [email protected] [email protected] [email protected] [email protected] Secudur® Carbogen 5 10 l 2.2 m3 - For supplying oxygen to tissue C5 O95 (5 vol. % carbon dioxide, samples and microorganism 3 balance oxygen) 50 l 11.0 m cultures Westfalen Gassen Nederland BV Westfalen Medical BV Westfalen Gas Schweiz GmbH Rigastraat 20 Postbus 124 Sisslerstr. 11/PF 3 - For creating a specific atmosphere 12 x 50 l bundles 132.0 m 7418 EW Deventer 7400 AC Deventer 5074 Eiken AG The The Netherlands Secudur® Individual mixture of 2 l 0.4 m3 Individual applications Phone +31 (0)570 - 63 67 45 Phone +31 (0)570 - 85 84 50 Phone +41 (0)61 855 25 25 Mix Secudur® gases, upon 3 10 l 2.0 m Fax +31 (0)570 - 63 00 88 Fax +31 (0)570 - 85 84 51 Fax +41 (0)61 855 25 26 request 50 l 10.0 m3 www.westfalengassen.nl www.westfalenmedical.nl www.westfalen-gas.ch 12 x 50 l bundles 120.0 m3 [email protected] [email protected] [email protected]

Westfalen AG Industrieweg 43 48155 Münster Phone +49 (0)2 51/6 95-0 Fax +49 (0)2 51/6 95-1 29 www.westfalen-ag.de [email protected] J5 1307 1T - P-TG-19.0/13-GB