INSIGHTS ON PHARMACEUTICAL INSPECTION

PHARMACEUTICAL INSPECTION SOLUTIONS

  • Bottles come in a wide array of sizes and configurations, reflective of their diverse use in the health sciences industry. Typically, they exhibit a screw top closure threaded onto the bottle mouth, though sealing properties ranges from elastomeric liners, to o-rings, to induction seals and reliance on plastic-to-plastic contact and compression. One specific trend is the increase in need to test sterile bulk containers or sterile API containers. As the industry continues to move toward outsourcing or even insourcing through a network of suppliers or sites, transport of sterile drug product or API is becoming increasingly common. These types of containers are traditionally challenging to test, but can be qualified prior to use or as a proof of concept using helium leak detection.

  • The pharmaceutical industry continues to bring breakthroughs in the field of new drugs and drug delivery systems amidst the increased scrutiny of the regulators. The packaging acts as the primary sterile barrier in drug delivery systems that safeguard the drug product through its life cycle. The efficiency of the primary sterile barrier and the functional components are of utmost importance to patient safety.

  • Ensure compliance with 21 CFR Part 11 and ensure 100% with a cutting-edge technology that inspects up to 400 vials per minute, ranging from 2ml to 100ml.

  • There are myriad combination systems to weigh and detect metal foreign objects in food. More compact that separate checkweighers and metal detectors, some combine important functions like program changes, alarms and rejection statistics in the checkweigher software. Now systems are available with the latest technology: multiscan metal detection technology.

  • With the advent of more advanced drug development for a wide variety of injectable compounds and an increasing preference for self-administration, prefilled syringes are the largest parenteral package growth sector. In many ways, the prefilled syringe is more complex and intricate in comparison to a traditional vial, a sealed ampoule, or bottles with screw top closures. They have multiple sealing sites that require integrity, but there is also a functionality piece associated: the syringe plunger must be able to deliver a dose, and thus, is movable.