Gas cylinder for the pharmaceutical industry PHARGALIS™ 1

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Summary
PHARGALIS™ 1: pharmaceutical-grade nitrogen for processes requiring high quality and safety standards. Used as an inerting gas to protect sensitive products from oxidation and contamination, and to maintain controlled atmospheres during production, packaging and handling.

Applications

• Inerting of intermediates and finished products (reagents, excipients, pharmaceuticals, medical devices).
• Pneumatic transfer of materials on production lines where pharmaceutical quality is required.
• Cryogenic processes and cryomilling in liquid form (solidification, prilling, spray congealing).
• Pressure equalization in freeze-dryers (breaking vacuum).
• Bioproduction: removal of excess CO2 in bioreactors and atmosphere control for cell culture.

Quality, compliance and traceability
PHARGALIS™ 1 is formulated to meet major pharmacopoeias (Ph. Eur., USP-NF, JP). Manufactured and controlled in line with Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) applicable to pharmaceutical excipients. EXCiPACT™ certified; each batch is delivered with a Certificate of Analysis (CoA) ensuring traceability and compliance.

Benefits

• Compliance with pharmacopoeias and GMP/GDP requirements, facilitating supplier audits.
• CoA and product dossier available to simplify incoming controls and quality documentation.
• PHARGALIS™ Smart Quality offering: structured, centralized documentation for quality management.

Environmental commitments
Production and filling into cylinders and bundles are carried out at certain sites using 100% renewable electricity to reduce the carbon footprint of supplied gases.

Supply forms
Available as compressed gas (cylinders in various sizes, cylinder bundles) and as liquid (bulk). Equipment is compatible with standard industrial installations.

Safety & transport information
Main hazard: asphyxiation at high concentrations. Non-flammable. Transport designation: Compressed gas. UN No.: 1066. ADR class: 2. Classification code: 1A.

Characteristics / technical specifications

• Product reference: I4070
• Physical state: gaseous
• Relative density (gas, air=1): 0.97
• Relative density (liquid, water=1): 0.8
• Molecular weight: 28.01 g/mol
• Valve connection: AFNOR C (21.7 x 1.814 SI - right male); bundle connection: 38x2 (S)
• CAS No.: 7727-37-9
• Composition / purity: N2 ≥ 99.5% (single component)
• Impurities (examples, see technical datasheet for full details): H2O (5 bar) ≤ 67; O2 ≤ 5; CO ≤ 5; CO2 ≤ 300; sum O2 + Ar ≤ 0.5% ensuring N2 ≥ 99.5%
• Color: colorless
• Odor: odorless
• Shelf life: 60 months
• Conformity: conforms to the current editions of pharmacopoeias (Ph. Eur., Ph. Eur. low oxygen, USP-NF, JP-Ph) and is produced according to GMP guides applicable to pharmaceutical excipients.
• Delivery: each batch supplied with a Certificate of Analysis (CoA) to ensure traceability and facilitate quality management.