The FDA issued the first warning letter citing failure to comply with requirements of the DSCSA amendments to the FD&C Act. This article takes a close look at this warning letter, but first it examines why McKesson may have received the first warning letter in this category, and explains why pharmaceutical manufacturers should care and what precautions they should take.
This guide explains the concept of metal detector sensitivity, key factors that impact it, and why a small difference in spherical sensitivity performance can mean a big difference in contaminants detected.
This white paper provides an explanation of the differences between validation, verification and routine performance monitoring as well as an overview of recommended test methods for different types of metal detection systems.
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.
A vaccine-focused biotechnology company approached LIGHTHOUSE to help investigate a phenomenon observed in liquid vaccine product stored at -80°C. During QC testing, a number of vials were found to have an overpressure. This phenomenon represented a serious safety risk and LIGHTHOUSE was asked to support an investigation to identify the root cause.
Laser-based headspace provides yet another alternative approach for detecting microbial contamination in sterile pharmaceutical product allows for quicker, more sensitive, accurate, and reproducible test results when compared with conventional, growth-based methods.
This application note describes how laser-based headspace analysis is used for the rapid non-destructive determination of headspace oxygen levels in pre-filled syringes. Data is presented demonstrating two major applications of this technique: 1) headspace oxygen monitoring on a pre-filled syringe line filling oxygen-sensitive product, and 2) container closure testing of pre-filled syringes.
Hermetic stick packs and sachets are the optimal packaging solution for single-dosed powder products. Our high-precision dosing serves to protect patients and allows controlled use of the medication. Thanks to the deep filling of the pouches, the product is used optimally. For expanded product protection and guaranteed efficacy, the contents of the package can also be gas-flushed as part of the packaging process for the patient's health.
Drug Delivery Devices offer the patient optimal application comfort and maximum safety. Most devices containing a medical ingredient are sensitive to humidity, oxygen and light. Our sealing technologies offer the perfect protection for the quality and hygiene of your products. For expanded product protection and guaranteed efficacy, the contents of the package can also be gas-flushed as part of the packaging process or by adding a desiccant pouch.
Hermetically sealed flow packs protect Blow-Fill-Seal (BFS) vials from external influences. Liquids and their active ingredients are often sensitive to humidity, oxygen and light. With our hermetic sealing technologies, we can guarantee the consistent quality of your products. The optional gas flushing of the package content in the packing process not only extends the protection level of the product, but also ensures its efficacy.
Patient safety and quality have top priority. Therefore, you should reliably protect your sensitive products from external influences such as humidity, oxygen and/or light. To produce hermetic flow packs, you can choose between our highly efficient heat or ultrasonic sealing technology. Our horizontal flow wrapping machines produce up to 350 high-quality hermetically sealed packages per minute.
Sensitive products, such as glass ampoules and syringes, require especially gentle and safe product handling, and a high degree of pack style flexibility. Our flexible cartoning solutions ensure that your products are securely packaged, in vertical or horizontal position or in multiple layers, with or without product holder. In addition, we offer optional versions with various opening aids, reclosure functions as well as tamper evidence applications. Product information and/or package inserts can be included in the carton box.
Serialization solutions enabling easy tractability and tracking of individual product packages.
Fully automated aggregation, compliance with regulations and industry standards, and flexibility and modularity. Solutions for the marking, verification and Code verification of aggregated product packages from carton to crate.
GlobalVision Color Inspection is the first digital inspection solution for color management for PDFs and printed components. The tool inspects colors and reports any differences outside a defined color threshold. Instead of manually checking colors by eye, users can detect and communicate color differences with color reports alongside their proofs for approval.
