Product Description

Applicable Samples

Packaging pouches, infusion bags, glass bottles, plastic bottles, vials, ampoules

Product Introduction

The ST-MIST01 microbial ingress seal tester integrates alternating positive and negative pressure testing functions in one unit. It is used for microbial ingress seal integrity tests of sterile packages including vials, ampoules, infusion bags, pre-filled syringes and eye drop containers. Customization is available to meet seal detection requirements for more products that require positive and negative pressure testing conditions.

2. Product Features

1. Integrated positive & negative pressure design, supporting free selection of multiple microbial ingress seal test items.
2. Pneumatic system adopts imported international brand components with pressure accuracy of Class 0.25.
3. Equipped with imported high-speed high-precision sampling chips to guarantee real-time and accurate test data.
4. One-click automatic test operation; vacuum level, pressurization and pressure holding time are presetable. Testing starts immediately after parameter entry.
5. Automatic constant-pressure air replenishment to maintain testing under preset pressure conditions.
6. Automatic backflushing and unloading for simple and smooth test completion.
7. Large-volume stainless steel tank allows high-temperature disinfection, improving test accuracy.
8. 7-inch large color touch screen with real-time test curve display for quick result review and historical data query.
9. Multi-level user authority management, GMP-compliant, with optional test record audit trail function.
10. Password login on startup to avoid equipment misoperation by unauthorized personnel; four-tier login and operation authority management.
11. Optional professional GMP computer software with abundant functions, supporting test data export, electronic signatures and pharmaceutical factory compliance requirements.
12. Dual power supply design with independent power supply for measurement-control and execution systems to ensure stable instrument operation.
13. Standard built-in mini thermal printer for fast test report output.
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3. Main Application Fields

Basic Applications

• Seal integrity test for vials and ampoules
• Seal integrity test for infusion bags and pre-filled syringes
• Seal integrity test for eye drop containers

Extended Applications

Customized solutions available for diversified seal testing demands

4. Test Principle

The microbial ingress test method, also known as microbial challenge test, is a widely adopted seal integrity detection method, which usually adopts vacuum or overpressure challenge conditions.

Conduct media simulation filling in accordance with media fill validation protocols, followed by stoppering and crimping. After visual inspection and sterilization in validated sterilizers, immerse the sealed part of the container into high-concentration bacterial suspension to fully contact the internal surface of the seal with the medium. The neck and outer sealing surface of the sample shall be fully submerged in the bacterial suspension. After soaking for a specified duration, take out the samples and incubate regularly to check microbial ingress and verify the integrity of the container closure system. Positive control tests are required to confirm the medium’s growth-promoting ability.

5. Technical Specifications

Note: Customized containers, fixtures and test procedures are required for different standard implementations.