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Pharmaceutical Package Distribution Testing

The pharmaceutical industry’s products and requirements present challenges for package designers that can all be met.

Laboratory-based Pharmaceutical Package Distribution testing (also known as Transit Testing) exposes samples to inputs such as impact, compression, vibration, environmental conditioning, and simulated low-pressure (high altitude) to replicate the distribution environment. Several ASTM and ISTA test protocols are available, providing package system validation methodologies for all distribution methods.

PHARMACEUTICAL PACKAGE TYPES

Shipping Container – Evaluating the product’s primary, secondary, and tertiary packaging layers against stated requirements and safety levels may involve Distribution Tests such as impact, compression, loose load, and stacked vibration. Material Tests like Mullen burst, edge crush, and pin adhesion evaluate packaging material properties.

Pallet or Skid – The performance of the product’s tertiary packing layer, usually a pallet or skid, must be confirmed. A good test machine is the Incline Impact (Conbur), to evaluate the shipping unit’s ability to protect from horizontal or side impacts.

Bulk Container Qualification – Drums, bags, or crates containing bulk quantities or raw materials must be qualified before use. Tests such as vehicle and stacked vibration, low-pressure (high altitude), concentrated impact, and mechanical handling are oftentimes used in evaluating bulk material containers.

Resources

WESTPAK white papers

Typical Procedures/Protocols

ASTM D880
ASTM D999
ASTM D1185
ASTM D4169
ASTM D4332
ASTM D4728
ASTM D6055
ASTM D6179
ASTM D6344
ASTM D6653
IEC 60068-2
ISTA 1A thru 6-SAMSCLUB

WESTPAK Capabilities

(1) Tumble Tester
(3) Horizontal Impact Testers
(17) Vertical Vibration Test Systems
(3) Horizontal Vibration Tables
(8) Drop Testers
(8) Shock Test Systems
(4) Compression Testers