Next-Generation Pharmaceutical Packaging Solutions: Regulatory Compliance, Supply Chain Integrity, and Sustainable Primary & Secondary Containment

Mauser manufactures primary and secondary pharmaceutical containers in facilities certified under ISO 15378 (Primary packaging materials for medicinal products) adhering strictly to cGMP principles. Our polymer resins comply with FDA 21 CFR 177.1520 (Olefins) and European Pharmacopoeia (EP) 3.1.3 specifications. Furthermore, our cleanroom manufacturing environments minimize particulate contamination in alignment with EU GMP Annex 1 recommendations for non-sterile and pre-sterilized packaging components. Full certificates of analysis (CoA) accompany every manufacturing lot.

We conduct standardized Extractables testing in accordance with PQRI (Product Quality Research Institute) and USP <1663> / <1664> guidelines. Controlled extraction studies utilize multiple solvent systems (water, ethanol, hexane) across elevated temperatures, analyzing organic compounds, volatile organic acids, and inorganic trace elements via GC-MS, LC-MS/MS, and ICP-MS. We provide drug manufacturers with pre-compiled E&L data dossiers to accelerate qualification of bulk API Jerrycans, IBC liners, and lined steel drums.

Direct primary contact packaging for medicinal products currently requires 100% virgin USP Class VI resin due to zero-contamination requirements. However, PCR resin can be safely and effectively deployed in secondary and tertiary packaging—such as outer protective overpacks, non-contact IBC frames, plastic pallets, and industrial transport pails. Mauser’s high-purity Infinity Series PCR resin utilizes advanced sorting and decontamination technologies, allowing pharmaceutical companies to significantly lower Scope 3 carbon emissions without exposing drug formulations to contamination risk.

The required UN marking depends on the hazard class, packing group (I - High Danger [X], II - Medium Danger [Y], III - Low Danger [Z]), vapor pressure, and density of the pharmaceutical substrate. For instance, aggressive organic solvents often require UN 1A1 (steel tight-head drum) rated X1.8/300. Composite IBCs intended for liquid intermediates are certified under UN 31HA1/Y. Mauser containers are independently tested and stamped with valid UN certification marks compliant with IMDG (maritime), ICAO/IATA (air), and ADR/RID (land) transport codes.

Mauser enforces global Quality Management System (QMS) standardization. Raw materials are sourced under strict global resin specifications from pre-audited supplier lists. Manufacturing machinery, mold tooling, melt-flow monitoring, wall-thickness ultrasound sensors, and automated vision inspection systems are identical across sites. Change control procedures guarantee that resin formulation, machine parameters, or mold designs cannot be altered without formal customer notification and qualification, ensuring seamless multi-site validation.

Through our global Recover Syst-M program, Mauser manages container collection from pharmaceutical manufacturing sites worldwide. Empty composite IBCs undergo inner bottle replacement (rebottling) or automated high-pressure multi-stage washing using validated cleaning agents. Reconditioned containers are leak-tested and re-certified for industrial re-use. Where container re-use is restricted due to hazardous chemical exposure, containers are processed in our closed-loop recycling plants, converting reclaimed HDPE into high-grade industrial plastic products.