Mirror-Finish Sanitary Containers for Pharma

Product Overview

In the pharmaceutical manufacturing landscape, maintaining sterility and compliance is paramount. Our Mirror-Finish Sanitary Containers are engineered to meet the stringent demands of pharmaceutical production, offering a reliable solution for storing and processing raw materials, intermediates, and finished products. Crafted from high-grade SUS 316L stainless steel—a material renowned for its superior corrosion resistance, acid resistance, and pitting resistance—these containers ensure optimal hygiene and product integrity throughout the production cycle .

Available in a comprehensive range of sizes, our containers cater to diverse operational needs, with nominal volumes ranging from 2m³ to 50m³ and corresponding real capacities from 2.05m³ to 50.5m³ . Each unit features a precision-engineered design with nominal diameters spanning 1000mm to 2800mm, ensuring compatibility with various production scales and facility layouts. All containers adhere to international standards, including FDA cGMP, EMA Annex 1, and ASME BPE, guaranteeing compliance with global pharmaceutical regulations . The mirror-finish inner surface, achieved through electrolytic polishing, eliminates surface irregularities, preventing residue buildup and facilitating thorough cleaning—a critical factor in preventing cross-contamination .

Technical Specification

Product Features

Superior Material and Surface Treatment

Constructed from SUS 316L stainless steel (wetted parts), our containers outperform standard SUS 304 alternatives by offering enhanced resistance to intergranular corrosion, even in welded areas . The electrolytic polishing process creates a Ra ≤ 0.8μm surface finish, which not only minimizes bacterial adhesion but also simplifies cleaning procedures. This surface treatment meets the strictest cleanability requirements outlined in pharmaceutical guidelines, ensuring no buffing powder or contaminants remain on contact surfaces .

Precision Engineering and Customization

Each container is meticulously designed with inlet/outlet diameters ranging from 50mm to 89mm and manhole diameters of 400mm to 500mm, facilitating efficient material transfer and easy access for inspection and cleaning . Mounting dimensions are optimized for versatility, with overall lengths (L) from 2720mm to 8860mm, ensuring seamless integration into existing production lines. Recognizing that pharmaceutical processes vary, we offer customization options to accommodate specific temperature, pressure, and operational requirements, as highlighted in our design flexibility commitment .

Applications

Raw Material Storage

The 2m³ to 10m³ containers are ideal for storing pharmaceutical-grade powders, granules, and liquids, with their compact design fitting seamlessly into laboratory and small-scale production environments. The mirror-finish surface prevents material adhesion, reducing waste and ensuring accurate batch consistency.

Intermediate Processing

For medium to large-scale operations, our 20m³ to 30m³ containers excel in intermediate mixing and processing stages. Their generous manhole diameters (500mm) allow for easy loading of additives and sampling, while the 89mm inlet/outlet ports support high-flow material transfer without compromising sterility .

Large-Scale Production

The 50m³ container, with its 2800mm diameter and 8860mm length, is engineered for bulk storage and large-batch processing . Its design accommodates the high-volume demands of API production and formulation, adhering to the strictest contamination control strategies (CCS) mandated by modern pharmaceutical standards .

FAQ

What standards do these containers comply with?

Our containers meet FDA cGMP (21 CFR Part 211), EMA Annex 1 (2025), and ASME BPE standards, ensuring adherence to global pharmaceutical regulations . They are also validated for extractable and leachable compliance, critical for maintaining product purity.

How should the containers be cleaned?

Follow a three-step process: (1) Remove visible residues with purified water and a nylon scrubber; (2) Disinfect using approved agents (e.g., 1% Teepol solution or 10% glacial acetic acid for specific residues); (3) Rinse thoroughly with purified water and air-dry . The mirror finish minimizes residue retention, simplifying cleaning validation.

Can containers be customized for specific processes?

Yes. We offer customization for temperature/pressure ratings, port sizes, and mounting configurations to suit unique operational needs. All customizations undergo rigorous testing to maintain regulatory compliance.

What is the significance of SUS 316L over SUS 304?

SUS 316L contains molybdenum, enhancing resistance to corrosion from acids and salts—common in pharmaceutical formulations . Its low carbon content prevents intergranular corrosion in welded areas, ensuring long-term durability in harsh processing environments.

By integrating advanced materials, precision engineering, and regulatory compliance, our Mirror-Finish Sanitary Containers set the standard for hygienic pharmaceutical storage and processing, supporting safe and efficient drug production worldwide.