Henll Pharmaceutical Large Bag Packaging Equipment: Sterile and Efficient Solution to Meet Strict GMP/FDA Standards

The pharmaceutical industry has extremely high requirements for the cleanliness, sealing performance, and data traceability of large bag packaging (25-50kg) for raw materials and excipients. Henll Company has launched an intelligent large bag packaging system for the pharmaceutical industry, which is specifically designed for powder and granular drugs. It addresses issues such as cross-contamination and inefficiency, helping pharmaceutical companies pass global compliance certifications.

Four Major Pain Points of Large Bag Packaging in the Pharmaceutical Industry and Henll's Solutions

Pain Point 1: High Risk of Cross-Contamination, Difficulty in Meeting GMP Compliance

Manual operations can easily introduce dust and microbial contamination, failing to meet the requirements of GMP Annex "Sterile Drug Products."

✅ Henll's Solution:

Fully enclosed stainless steel cabin + FFU laminar flow purification system (cleanliness ≥ ISO 5 level)

Equipped with VHP hydrogen peroxide sterilization module to meet CIP/SIP online cleaning requirements

Pain Point 2: Inadequate Packaging Sealing, Susceptibility of Drugs to Moisture and Oxidation

Traditional sealing allows moisture penetration, affecting the stability of raw materials.

✅ Henll's Solution:

Triple heat sealing technology (sealing strength ≥ 80N/15mm)

Optional vacuum nitrogen filling/aluminum foil composite film, with residual oxygen content ≤ 0.3% and humidity ≤ 10% RH

Pain Point 3: Low Manual Efficiency, Proneness to Errors in Batch Records

Manual weighing is slow (≤ 100 bags/hour), and paper records are difficult to trace.

✅ Henll's Solution:

High-precision weighing module (±0.1%) + robotic arm automatic palletizing, efficiency up to 400 bags/hour

Electronic batch record (EBR) system automatically generates data packages, compliant with FDA 21 CFR Part 11 requirements

Pain Point 4: Single Packaging Specification, Difficulty in Flexible Production

Product changeover requires lengthy debugging, unable to meet the needs of multi-variety and small-batch production.

✅ Henll's Solution:

Modular design, 1-button switch between 2kg/1000kg specifications, changeover time ＜ 15 minutes

Supports various packaging materials such as stand-up bags and four-side sealed bags, suitable for API, intermediates, and other scenarios

Three Major Values of Choosing Henll Pharmaceutical Large Bag Packaging Equipment

Zero Contamination Assurance: ISO 13485 medical device certification, with a 10-year record of 0 contamination accidents

Cost Reduction and Efficiency Improvement: 90% reduction in manpower, packaging loss rate ＜ 0.05%, saving over 2 million yuan annually

Global Compliance: Meets EU GMP, FDA, WHO certification requirements, facilitating drug exports

Customer Case Study

After adopting Henll's equipment, a biopharmaceutical company in Jiangsu achieved a sterile packaging qualification rate of 99.99%, successfully passed an on-site FDA audit, and saw a 300% increase in overseas orders.