Insights On Pharmaceutical Inspection

1. GF Pharmaceutical Bag Inspection 4/29/2021

   The GF Bag Inspection Machine offers the ideal solution to ensure parenteral products are free of foreign products using multi-point vision station during bag positioning and spinning phase. Optimized design and structure allow for simple operation, quick changeovers, and low maintenance.

2. The Importance Of Package Integrity To Shelf Life Of Products 6/9/2020

   Pharma Tech Industries (PTI), a contract manufacturer and packer of pharmaceuticals, medical devices and personal care products, is focused on exceeding customers’ expectations. They rely on x-ray, metal detection systems and checkweighers to consistently achieve their high quality standards

3. How To Ensure Container Closure Integrity Of Combination Drug Products 8/24/2021

   The rapidly increasing preference towards combination pharmaceutical products continues to fuel innovation, while presenting unique challenges in implementing a container closure integrity (CCI) testing strategy. Common examples of combination products include prefilled syringes, pen injectors, inhalers, and drug-eluting stents, orthopedic products, infusion pumps and more. The packaging for combination products can be just as complex as the products themselves. Hence, container closure integrity testing in line with current USP <1207> guidance and regulation is critical to ensure package integrity.

4. Experimental Design And Statistical Tools For Non-Destructive Package Integrity Testing Systems 3/26/2020

   This short podcast focuses on experimental design and statistical tools we use with non-destructive package integrity test systems. PTI’s Veripac inspection systems are deterministic test methods for package integrity testing that produce reliable and robust quantitative test data.

5. Gene Therapy: Maintaining Sterility At Low Temperature Storage 6/23/2020

   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.

6. 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.

7. An Introduction To High Voltage Leak Detection (HVLD) Technology 4/8/2021

   It is understood that no matter how carefully a product has been prepared, it would still be unsafe for human use if the container has a pinhole, a crack or a defective seal. There are a variety of methods widely used in the detection of pinholes, cracks and defective seals in containers however a majority are destructive causing the loss of good product and packaging components. Read more to learn why the High Voltage Leak Detection (HVLD) system is totally free from these shortcomings and has additional advantages for ensuring seal integrity.

8. Effects Of X-Ray Inspection On Pharmaceutical Products 12/12/2019

   Some manufacturers still have reservations about adopting x-ray inspection as a safe method of product inspection. This white paper examines the potential effects of x-ray inspection on pharma products.

9. 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.

10. CCI For Combination Products: Assembling The Package Integrity Profile For Autoinjectors 4/20/2020

    Due to their complexity, combination products, specifically autoinjection systems, present unique challenges in implementing a container closure integrity (CCI) testing strategy. This is further complicated by a pervasive, though diminishing, tendency for companies to consider CCI only at the final product-package lifecycle stage, an approach where combination products will highlight the pitfalls.