Cleanliness Requirements for Fiber Drums in the Pharmaceutical Industry

In the pharmaceutical industry, packaging plays a vital role in maintaining product quality, safety, and regulatory compliance. Fiber drums are widely used for storing and transporting bulk pharmaceutical ingredients, such as active pharmaceutical ingredients (APIs), excipients, and powdered compounds. However, strict cleanliness standards must be met to ensure they are suitable for this highly regulated sector.

 1. Clean Room Compatibility

Fiber drums used in pharmaceutical applications must be manufactured, assembled, and packaged in clean or controlled environments to avoid contamination by dust, fibers, or foreign particles.

 2. Compliance with Regulatory Standards

Pharmaceutical-grade fiber drums should comply with international packaging regulations, including:

• FDA 21 CFR (for materials in contact with pharmaceuticals)

• USP <661> or <671> (for packaging systems)

• EU GMP guidelines

• ISO 9001 / ISO 15378 for quality and traceability in pharma packaging

 3. Use of Inner Liners

To meet hygienic requirements, fiber drums are often used with:

• FDA-approved PE, aluminum, or anti-static liners

• Double liners for sensitive or hygroscopic materials
  These liners prevent direct contact between the product and the drum wall, ensuring product purity and preventing cross-contamination.

 4. Low Particulate Generation

High-quality fiber drums are made from tightly bonded kraft paper and resin systems to minimize dusting and particle shedding — critical for maintaining cleanroom standards in pharmaceutical production areas.

 5. Tamper-Evident & Secure Sealing

Lid systems (steel or plastic) must support tamper-evident seals, while closures must provide airtight protection to prevent microbial ingress or moisture contamination.

 Conclusion

To be accepted in pharmaceutical applications, fiber drums must be:

• Produced under strict hygienic conditions

• Compatible with FDA and GMP guidelines

• Equipped with pharmaceutical-grade liners

• Low in particle generation and free from contaminants

At Nanjing Shengjiang Packaging, we offer clean, compliant fiber drums tailored for pharmaceutical use — helping clients ensure product integrity, meet audit requirements, and streamline global logistics.