Bottle Solutions
PharmaTainer™
Stability Vials
The SaniSure® PharmaTainer™ 10ml Stability Vials, in PET or PC, enable customers to evaluate and monitor drug substance testing and sample storage at -80°C.
Small containers are beneficial in the early stages of the drug development cycle when materials are only available in small quantities. Later in the product lifecycle, using a small stability container minimizes the consumption of valuable drug substances in testing.
Overview
PharmaTainer™ Stability Vials
Applications
- Stability studies
- Sampling
- Samples storage
Benefits
- Same resins as larger volumes
- HDPE cap with a double seal system
- Certified sterile SAL 10-6
- Cap torque chuck available
Specifications
- Resins ADCF, grade medical with a DMF
- Certified to meet USP788 for particulate
- Endotoxins tested according to USP 85.
- Certified Sterile SAL 10-6 according to an ISO 11137 sterility program
- Complete file validation with E&L and Biocompatibility studies (ISO 10993-6,-10,-11)
- USP class VI and 21CFR compliant
Top-quality single-use rigid containers
Traceable
Serial number to allow the bottle to be traced in each step of the process.
Easy to manipulate
The PharmaTainer™ design includes a grip ensuring you can manipulate the bottle without difficulty.
Compliant
Our manufacturing process is ISO 9001-2015 certified, and our cleanrooms are ISO 14644 Class 7 compliant.
No leakage
Our caps are manufactured with a double seal to provide a fail-safe closure. No gasket is required, and no overwinding is possible.
More in PharmaTainer™ Bottle Solutions
Incorporate accessories to your PharmaTainer™
PharmaTainer™ Bottle Solutions can be combined with accessories, like 2-, 3-, and 4-ported caps with hose barbs, closure/opening chucks, and a range of sterile and individual replacement caps in HDPE.
Reach out to us for superior product quality and customization.
