Testing of compressed gases is a GMP requirement when such gases are used in cleanroom applications. It is critical for such testing to occur since
Qualification of Vertex50 to measure and detect ≥50nm trends in UPW systems The Vertex50 has TRUE sensitivity at 50nm has been qualified to measure and
Lighthouse offers an opportunity to sample the contamination level in compressed gases. In the electronics industry as well as the Pharma industry contamination control of
Good Automated Manufacturing Practices (GAMP). GAMP is both a technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for
With the never ending shift towards continuous quality improvements within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP
A PQ is a performance qualification which is conducted prior to a system becoming operational. The PQ tests the system to ensure it meets its
The following questions will help you ask the right questions when implementing a system thatadheres to 21CFR Part 11. It is important to satisfy the
21 CFR Part 11 outlines the federal requirements that help to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records and
Air Sampler impaction technology has been around for decades. However the d50 is a little know aspect of air sampler technology design and it plays
Vaporized Hydrogen Peroxide (VHP) is a powerful chemical used to sterilize surfaces andequipment in the cleanroom, specifically in the medical equipment and pharmaceuticalindustries. It can
A cleanroom is a specifically designed room that controls contamination. Cleanrooms are used in practically every industry where small particles can adversely affect the manufacturing
Cleanrooms require air filters in order to trap contaminants from entering the cleanrooms air supply through its HVAC system. Cleanrooms are controlled environments where the
Particle Counter management is a critical process in ensuring particle counter health and data integrity. The accuracy of the data from particle counters is critical
Cleanroom Certification is a process of validation. This validation process certifies that the Cleanroom operating conditions meet the intended design parameters. Room Particle Counts are
Water is one of the major utilities used by the pharmaceutical industry. Different grades of water quality are required depending on the different pharmaceutical uses.
We are all too well aware of the adverse effects of particulate matter contamination within parenteral injectable pharmaceutical products and the consequences for patient safety.
An Environmental Monitoring System (EMS) is very different from a Building Management System (BMS). A building management system (BMS), also known as a building automation
This Whitepaper is intended to assist users that are looking to integrate their ApexZ unit into LMS Pharma’s facility control/monitoring system. This document covers the
Abstract This article discusses the mechanisms of particle deposition onto cleanroom surfaces. The main mechanism for particles above 0.5 µm is gravitational settling. Turbulent deposition
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