INSIGHTS ON PHARMACEUTICAL INSPECTION

• Seal-Sensor Airborne Ultrasonic Technology

  Seal-Sensor™ is an Airborne Ultrasonic Technology that inspects pouch seals non-destructively 100% online for defects. Seal-Sensor detects incomplete seals, partial or weak areas in seals, and common seal defects that affect product quality and shelf-life.

• Root Cause Investigation Into A Possible Container Closure Integrity Failure

  In cases where oxidation of the formulation causes discoloration and eventual degradation of the product, non-destructive headspace analysis tests can give deep insight into the root cause. Since the samples are not destroyed by the headspace analysis, further testing can be done to accurately correlate headspace conditions with other product characteristics.

• Automated In-Line Pouch Inspection System Assures Package Seal Integrity For Flexible Packaging

  PTI’s VeriPac LPX automated inline pouch inspection system assures package seal integrity of flexible packaging formats.  Non-destructive vacuum decay technology and ASTM Test Method F2338 provides automated quality control using high speed robotic pick & place handling. 

• Using Laser-Based Headspace Moisture Analysis For Rapid Nondestructive Moisture Determination Of Sterile Freeze-Dried Product

  Rapid water vapor determination with an optical method could replace the slow destructive traditional methods for the moisture analysis of freeze-dried product. A description of industry applications of headspace moisture analysis including freeze drying cycle optimization, lyo chamber moisture distribution mapping, and 100% moisture inspection of commercial freeze-dried product.

• Inline Weighing Technology Offers Additional Quality Check Features

  Protina Pharmazeutische GmbH produces high-quality preparations, such as medicine, food supplements and cosmetics. Alongside weight monitoring, the checkweigher used at Protina offers other important functions that support the company's system of strict quality management.

• Gene Therapy: Maintaining Sterility At Low Temperature Storage

  Bringing the first gene therapy for pediatric Spinal Muscular Atrophy to market in a leak and break resistant container which maintains sterility over product shelf life, through freeze and defrost cycles presented challenges. A combination of high-quality components created a proven system which ensured CCI over the product shelf life and low temperatures.

• Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids

  Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.

• OEE And Product Inspection Efficiency In The Pharmaceutical Industry

  Few industries are as heavily regulated as the pharmaceutical industry, as poor quality or otherwise defective pharmaceutical products can potentially have fatal results for end users. Manufacturers must perform a careful balancing act: weighing pressure to improve production speeds against the need to ensure compliance with government regulations. The purpose of this white paper is to provide an overview of the various components that go into measuring OEE, a method of obtaining a complete view of the efficiency of a production process, and then to discuss the ways in which product inspection equipment can affect OEE in the pharmaceutical industry.

• USP <1207> Updates Leak Testing Recommendations for Pharma Companies

  Package integrity is defined as a package’s ability to prevent product loss, maintain product sterility, and in some cases, prevent oxygen ingress or maintain sub-atmosphere headspace pressures.