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WHITE PAPERS & CASE STUDIES

  • Battling Counterfeit Medicine Through Packaging Serialization

    Medicines need to be packaged in a way that allows counterfeits to be quickly and easily identified, preventing their circulation and/or eliminating drug recalls. An essential element of this process is package serialization. Outsourcing work with contract manufacturers is one such way to be fully prepared for serialization implementation across all production lines.

  • Serialization: Optimizing, Planning And Implementation

    Increased globalization in the supply chain for prescription drugs has also increased the distribution of counterfeit drugs. Product serialization enables manufacturers and distributors to protect consumers from potentially harmful counterfeit and stolen drug products by improving supply chain tracking, visibility and 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.

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

    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.

  • 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.

  • Pharmaceutical Manufacturer Utilizes Checkweighers To Identify Inaccurately Filled Product

    In no other industry is the need for product quality and process reliability as critical as in the pharmaceutical industry. Sanofi-Aventis is the global leader in core medical areas, such as diabetes/metabolism, the cardiovascular system, thrombosis, the central nervous system, internal medicine, oncology and prevention through progressive vaccines. Checkweighers check vital insulin: in the Injectables Division, where liquid drugs such as different types of insulin or drugs for emergency medicine are produced, the packaged medical compounds are subjected to final checks using a dynamic checkweigher.

PRODUCTS & SERVICES

Dec Group specialists offer full support for the integration of the serialization process into the pharma industry supply chain.

With over 80 serialization lines across our global site network, PCI is a true market leader in packaging serialization and anti-counterfeiting.

Used Safeline metal detector, model PHARMXSR4V1/26X22, module serial# 32625, serial# 13123.

The pharmaceutical industry continues to lead industries in terms of quality requirements and the value of data. The shift to more automated processes is less about the cost of human capital, but more about the pursuit of quality. The European Medicines Agency (EMA) updated Annex 1, driving for 100% inspection on fused containers and appropriate quality test measures for applications based on level of risk. The United States Pharmacopeia (USP) revamped Chapter 1207 on container closure integrity (CCI) to be prescriptive of deterministic technologies and encourages a deeper understanding of a container’s CCI requirements. The FDA continues to drive a ‘quality culture’ agenda versus a ‘compliance culture’, and the FDA has been explicitly targeting data integrity as a campaign for assuring quality. Every regulatory and guidance body is driving towards more reliable and accurate test methods.

Bora has packaging facility to package sachets (Tainan), blisters (Tainan), tablet and capsule products. The entire packaging area is divided into primary and secondary packaging areas. Primary packaging area is designed to meet ISO 8 requirement for finished products are packed into bottles with desiccants, sealed and capped. Packaging rooms, gowning rooms, and support rooms (equipment cleaning, drying and storage rooms) are physically separated and cascade of pressurization system is used to control dust migration and prevent cross contamination.

Unused Seidenader inspection system, type V90-AVSB/60-LR semi automatic inspection units, L-R orientation, currently set up for syringe inspection, with Sortec feeding system, 460 volt, Seidenader serial#, 117066

Unused Seidenader inspection system, with (2) type V90-AVSB/60 Seidenader semi automatic inspection units, (1) L-R unit, (1) R-L unit, currently set up for syringe inspection, with Sortec feeding system, 460 volt, Seidenader serial #'s, 11706A, 11706B.

There is an increasing demand for CCIT (Container Closure Integrity Testing), in the pharmaceutical industry that are driven by strict FDA guidelines requiring a sterile barrier. Whether you are testing sterile barrier, a moisture barrier or general protection packaging we can offer nondestructive container closure integrity test equipment.