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.

Stability Vials for drug substance testing

PharmaTainer™ Stability Vials are manufactured from the same materials* used in larger PharmaTainer™ bioprocess storage containers. The 29 mm HDPE closures feature the same double-seal system found throughout the PharmaTainer™ product range.

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

LOT 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 with no difficulty.

Compliant

Our manufacturing process is ISO 9001-2015 certified, and our cleanrooms are ISO 14644 Class 7 compliant.

No Leakage

Manufactured with a seal-first approach. No gasket is needed, and no overwinding.

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.