INSIGHTS ON LIQUID DOSE MANUFACTURING

• Headspace Oxygen Monitoring On A Pre-filled Syringe Line Filling Oxygen-Sensitive Product

  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.

• Container Closure Integrity Testing Method Development

  Recent regulatory revisions have also put emphasis on robust method validation for container closure Integrity test methods. This webinar covers approaches that can be used for method development for CCI testing in all phases of the product life cycle.

• Roller Bottles That Excel With ST, Vero, And MDBK Cells

  A study was conducted to compare the performance of Thermo Scientific Nunc Roller Bottles (1.2 and 2.5X) and 850 cm2 roller bottles from another supplier, for the culturing of ST, Vero, and MDBK cells.

• Common Fume Hood Containment Problems

  While there are “bad” fume hoods, anything wrong with the entire system (exhaust fan, ductwork, building configuration, regulative dampers) may cause a lack of containment in a hood.

• Validation Of A Glovebox Workstation

  Many existing research labs, pharmaceutical and biopharmaceutical manufacturers, and contract manufacturing organizations (CMO’s) are not designed nor are they equipped with the engineering controls to safely handle the manufacture of ADC’s. The safe manufacture of ADC’s requires more modern facilities, equipment, and engineering controls as well as programs, practices, and procedures to adequately protect the operators and the work environment. Read the steps that must be taken to consider a glovebox workstation fully validated to manufacture ADCs safely.

• The Keys To Superior Containment In Compounding Applications

  This paper reviews why very bad things happen when either quantity or purity of Highly Potent Active Pharmaceuticals is not properly maintained during the compounding process. 

• In-Process Monitoring Of Headspace Oxygen Levels In Parenteral Containers

  Using a high sensitivity detection technique known as Frequency Modulation Spectroscopy (FMS), LIGHTHOUSE rapid non-destructive headspace oxygen inspection can help streamline the monitoring of purge performance on the filling line. This paper demonstrates the correlation of the FMS rapid non-destructive technique for analyzing headspace oxygen levels with the most commonly used conventional destructive techniques for headspace oxygen inspection.

• Venting Fume Hood Base Cabinets — A Better Way

  Frequently, companies have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out. 

• Introduction To Laser-Based Headspace Inspection And The Application To 100% Container Closure Inspection

  Gain insight into the process, ensure the maintenance of sterility for finished product after capping, and meet current regulatory guidance using laser-based headspace inspection.