INSIGHTS ON PHARMACEUTICAL INSPECTION

• 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.

• PTI OptiPac Leak Detection System

  PTI’s OptiPac Leak Detection System is a deterministic non-destructive technology designed specifically for blister packs. OptiPac utilizes volumetric imaging under vacuum with topographic imaging to detect the presence and location of leaks.

• Versatile Pharmaceutical Weighing Platform That Provides High Accuracy And Throughput

  This video demonstrates the C3570 checkweigher system's extremely high weighing accuracy (from +/- 10 mg) on packages from 3g to 10kg. It is capable of running up to 600 packs per minute with product handling variants including side-grip conveyors, top and bottom conveyors, infeed timing screws and star-wheels which ensure smooth product flow.

• Test Method Development, Experimental Design And Positive Controls For Package Integrity

  Given that the experimental design has only two conditions, leaking and non-leaking, this variable is extremely important to understand. Proper use of positive controls and knowledge of how alternative approaches are applied to challenge a test method support the validity and reliability of the method.

• Dual-Lane Checkweigher Provides High-Throughput Tube Line Automation Inspection

  6/15/2020

  Teligent produces a diverse range of generic prescription topical and injectable pharmaceuticals. To automate inspection on their high-throughput tube line, they turned to a checkweigher with a two-lane configuration that matches their dual-lane filler.

• Applications For High Voltage Leak Detection You Might Not Be Aware Of

  4/27/2021

  High Voltage Leak Detection (HVLD), a technology first applied to pharmaceutical manufacturing in the 1970s, does not destructive to packaging components or cause the loss of good product like other inspection methods. HVLD is capable of handling any product as long as  the container is made of electrically insulated material and the product contains an electrically conductive solution. In this article you will learn more about other packaging applications that can be inspected with HVLD.

• Gas Ingress Methods As Replacement Of Blue Dye Ingress Testing For Container Closure Integrity

  3/10/2021

  Laser-based headspace analysis is a deterministic CCI test technique described in USP <1207> that measures gas which ingresses into a container through a leak defect. More recently, general headspace CCI test methods have been developed that both resemble and improve upon the traditional blue dye ingress test .This article describes the headspace gas ingress testing approach which is increasingly being implemented to replace blue dye ingress as a general CCI test method.

• Oxygen Sensitive Product: Comparing Oxygen Testing Methods

  3/7/2021

  The accurate determination of oxygen concentration as a critical quality parameter for oxygen-sensitive products is important across the product life cycle activities. Traditional methods for determining headspace oxygen levels in parenteral containers, such as electrochemical methods or gas chromatography, are slow and destructive. This article describes several case studies comparing non-destructive laser-based oxygen headspace analysis with electrochemical oxygen analysis and gas chromatography.

• A Holistic Strategy To Ensure Container Closure Integrity Of Sterile Injectable Vial Product

  1/25/2021

  Recent regulatory guidance has triggered changes in industry best practices in the area of container closure integrity testing (CCIT). However, assuring good CCI of sterile injectable product goes beyond CCI testing. A more science-based holistic approach that includes robust design & qualification of the process and the implementation of appropriate process controls is required. This article describes a framework enabling such a holistic approach to CCI that assures both the primary packaging and the process contribute to good CCI of sterile injectable vial product.