Packaging is the primary barrier between a product and its environment. Even microscopic leaks can compromise product safety, shelf life, and regulatory compliance.

For pharmaceutical packaging, container‑closure integrity is critical for sterility assurance. Regulatory bodies, including the FDA and USP, require robust methods to verify that sterile drug products remain protected. The vacuum decay method aligns with USP 1207, which recommends deterministic, reproducible methods for package integrity evaluation.

For food packaging, seal defects can lead to spoilage, contamination, and costly recalls. Vacuum leak testing helps manufacturers identify weak seals and pinholes before products reach consumers.

How to Solve Packaging Leakage? – Sumspring Offers Seal Integrity Testing Solutions

To ensure the seal integrity of pharmaceutical and food packaging before they leave the factory, Sumspring has launched the MFY-05S Negative Pressure Seal Tester, designed in compliance with international standards including USP and ASTM. The instrument operates on the vacuum decay (negative pressure) method, applying a vacuum to the sealed package and monitoring pressure changes in real time to accurately detect micro‑leaks. The MFY-05S is widely used across the pharmaceutical, food, medical device, daily chemical, and electronics industries for various packaging formats, including bags, bottles, tubes, cans, blister packs, and other sealed containers.

As an established manufacturer in the packaging testing instrument industry with nearly 20 years of experience, Sumspring has deep technical expertise and a strong track record in standards development. The company has actively participated in the drafting of seal integrity‑related standards for the 2025 edition of the Chinese Pharmacopoeia, and works closely with industry experts to study and interpret international standards. Sumspring is committed to providing professional, compliant, and reliable seal integrity testing solutions for pharmaceutical packaging materials and sterile packaging applications.

Sumspring Negative Pressure Seal Testers are designed with:

• High‑precision vacuum sensors for accurate, repeatable results
• User‑friendly touchscreen interfaces for easy operation
• Interchangeable vacuum chambers to accommodate various package sizes
• Audit trail and data management for GMP compliance
• Durable stainless steel chambers and reliable pneumatic components

Compliance with International Standards