This presentation discusses the basic definitions of extractables and leachables, including details from a case study done using prefilled syringes and a second using a single-use bag.
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.
In pharmaceutical formulating the elements are often not fully compatible and must be mixed following a strict procedure to obtain a stable and durable structure. This task is even more challenging when formulating with natural ingredients. The constant need to create new formulations or reformulate existing formulations requires thorough monitoring of formulation properties. This article outlines the crucial steps to be considered for a full and complete characterization of your formula.
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.
Rapid non-destructive headspace moisture analysis from LIGHTHOUSE enables fast moisture determination of statistical numbers of lyo samples.
This presentation features testing overviews for container closures, pharmaceutical glass and plastic and covers common tests and techniques for each.
Key risks for drug contamination are by humidity, oxygen or microbiological ingress, which can impact the drug stability throughout the product life cycle.
This webinar presents how to design and conduct studies to assess the total oxygen permeation rate of your pre-filled syringes, and how to determine if the permeation is primarily through the plunger or through the tip. Protecting oxygen-sensitive formulations during filling will also be discussed.
This paper provides an introduction to particle sizing comparing six widely used techniques, explaining how they work and what this means in terms of strengths and limitations.
Used Perkin Elmer Lambda 14 UV/VIS Spectrometer, with controls on unit, 230 volts, serial# 50134.
Automatic Tablet Press Enclosure designed to provide personnel protection tablet pressing operations involving a Carver Press 800 ANE with dimensions 35.43” x 23.62” x 39.37 [900mm X 600mm X 1000mm]. Enclosure features a polypropylene superstructure, black phenolic base dished to contain spills, and (3x) removable sliding doors for easy loading/unloading of equipment and processed product.
Our viscometers cover the whole viscosity range with 3 models: L for low-viscosity samples, R for medium-viscosity samples, and H for high-viscosity samples.
The FMS-Water Activity Analyzer is a non-destructive gas analyzer for making water activity measurements of solid dosage drug product samples.
For more than 40 years, Anton Paar has been a leading supplier of sample preparation instruments. The latest innovation, Multiwave GO, represents a masterstroke of Anton Paar's engineering. The newly designed and revolutionary Directed Multimode Cavity provides the best of both monomode and multimode microwaves. As in a monomode system, the microwaves are directed to the sample, providing highly efficient heating. As in a multimode system more than one sample can be digested in a single run.