Learn how rapid, nondestructive laser-based headspace analysis can support with data generation to demonstrate the maintenance of seal integrity during deep cold storage and transport.
Large molecule biopharmaceuticals can be prone to oxidation and to prevent this from occurring, the headspace is often purged with an inert gas during filling to ensure a longer shelf life.
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.
A majority of pharmaceutical gels are shear-thinning semisolids prepared by dispersing hydrophilic polymers into an aqueous vehicle. Proper mixing requires a good balance between agitation and shear.
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and process that provide critical advantages for sustainable initiatives.
Finding the right mixing equipment isn’t as simple as selecting an item from a menu. This article is a guide to considerations when choosing pharmaceutical mixing equipment and vendors for a facility.
Though delivering, unloading, staging, and assembling are required steps in all lab construction, there are design aspects of lab equipment that can contribute to its successful field installation.
A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.
Dry blending is an indispensable operation in the manufacture of multivitamins, sports supplements, herbal extracts, meal-replacements, green food powders and other nutraceutical products.
Used 1.5" Schenck volumetric feeder, model MODMC-IG-2A, stainless steel product contact surfaces, with approximately 1.5" diameter x 17" long discharge screw, driven by 1 hp motor, .5 hp hopper agitator, serial# 105850-06C-MECGM.
Komal's water demineraliser employ the modern ion-exchange technology to give to chemically pure water. A demineraliser removes these minerals from the raw water by an ion- exchange process. This process first exchanges the cations of the salt for the hydrogen ions and, then, exchanges the anions of the salt for the hydroxylions.
The MicroSphere is a clean, cost-effective C.A.I for sterile compounding, that is USP <797> compliant.
For more than thirty years, now the name of KOMAL Stands for the highest quality in pure and ultrapure technology for industry. With quality reference, innovative strengths and flexibility in design, we are the leading manufacturer of Centralized Ultra Pure water System.
Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) are systems designed for automatic cleaning and disinfecting without major disassembly and assembly work. We design, develop, manufacture, supply and install Mobile and Fixed CIP & SIP Units for sanitization and sterilization. The units are custom made, modular, skidded in automated or semi-automated Models as per the required time cycle for cleaning and sterilization as a part of cGMP requirements from portable to large fixed Multi-Tank system.