PharmaTainer™ bottles and carboys meet today’s requirements for bio-manufacturing storage and transport. We believe these are the best rigid single-use containers available today for safe, trouble-free mini-bulk storage of biologics.
What Makes PharmaTainers Better
Features & Benefits
Double-seal closure system: leakproof sealing.
Traceability by lot: tracks back to materials, operators, molding machine and related QC/QA records.
Traceability by serial number: provides a method for single unit inventory tracking.
2D optical code of serial number: allows registration and control of individual units using an optical reader.
Expiration Date: 5 years from date of manufacture.
Molded in ISO Class 5 environment: Allows compliance with USP <788> Particulate Matter in Injections standard without any problematic cleaning steps.
PET bottles have excellent gas-barrier properties.
New, state-of-the-art molding facility:
Molds only for biotechnology applications: no confusion with multiple quality standards.
Leading edge molding technology: precision molding with better control for high product quality and consistency.
Molding containers and closures: full control of container sealing system, no variation imposed by outside vendors.
Validation CD: a compilation of test reports, data sheets, drawings and other information to support the use of PharmaTainer products. This information is free, but is only provided under a non-disclosure agreement.
The Double-Seal Closure
PharmaTainer closures seal at two points; on the inside of the neck and also on the top flat rim of the neck. Tests have demonstrated that the closure system holds seal very well. The seal inside the neck is readily achieved when applying the closure by hand. Certain engagement of the rim seal requires application of a known amount of torque.
PharmaTainer packaging has been designed to pass through 3 levels of increasing clean environments and each level of packaging is clearly labeled with product identity, lot number, expiration date and a radiation
indicator dot. The following packaging scheme is true for all PharmaTainer bottles and carboys.
Carton: 4mm corrugate, with top & base protection sheets.
Carton Liner: 50µ LDPE monolayer film bag, tape sealed.
Level 2 Pack: 100µ LDPE monolayer film bag, heat sealed.
The user may be confident that the products are sterile as long and the innermost bag holds its vacuum.
Imprint and Unit Traceability
PharmaTainer bottles and carboys have black printed volume scales and traceability information.
Graduations: ±2% in appropriate increments to recommended capacity.
Traceability: Lot No., S/N, 2D S/N optical code, Expiration Date
PharmaTainer products are manufactured by Cellon SA serving biologics manufacturing customers since 1987.