TECHLEAD®
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| Brand | TECHLEAD® |
|---|---|
| Manufacturer | Tailin Biotechnology Co., Ltd. |
| Origin | Zhejiang, China |
| Model | AST-300 |
| Type | Fully Automated Sterility Testing Incubation & Detection System |
| Regulatory Alignment | USP <1223>, EP 5.1.6, ChP 2020 <9201>, FDA 21 CFR Part 11 |
| Temperature Control Zones | Three independent incubation chambers (30–37 °C and 20–25 °C) |
| Detection Time | As low as 8 hours for positive identification |
| Detection Limit | ≤5 CFU per test unit |
| Microbial Coverage | Bacteria, yeasts, and molds |
| Data Integrity | Audit-trail enabled, electronic signature compliant, ALCOA+ principles implemented |
| Method Compatibility | Direct inoculation method |
| Brand | TECHLEAD® |
|---|---|
| Manufacturer | Tailin Biotechnology |
| Origin | Zhejiang, China |
| Model | BIT-L01S |
| Type | Microbial Challenge & Dye Penetration Integrity Tester |
| Compliance Design | IP69-rated stainless steel test chamber, steam-sterilizable (125°C), CFR Part 11–ready data logging |
| Application Scope | Parenteral packaging, blister packs, vials, syringes, IV bags, medical device pouches |