Oct 8, 2022

The Ultra Pure Water Qualification of the Vertex50

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 detect ≥50nm particles in Ultra-Pure Water Systems (UPW). UPW systems are used in many industries worldwide to provide high purity water. Ultrapure water is a commonly used term in the […]

Oct 6, 2022

Gas Sampling Applications

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 compressed gas has been getting more important over the last few years. 

Sep 22, 2022

Cleanroom Validation from URS to PQ; ISPE GAMP5 2022 Edition & V Scheme Application for Cleanroom Monitoring Systems

Sep 15, 2022

Creating A Compliant Environmental Monitoring Program

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 and also 21CFR11 in the context of GAMP 5 requirements. How a Company creates, maintains, retrieves, corrects and controls data can affect product quality. How a company reacts to out […]

Pharma 4.0
Sep 14, 2022

What is Pharma 4.0?

Welcome to the age of the internet! Pharma 4.0 is the International Society for Pharmaceutical Engineering’s (ISPE) version of Industry 4.0, also called Smart Factory. Essentially, Industry 4.0 is the fourth industrial revolution. It encapsulates the changes we are seeing happen in the world because of the internet. Pharma 4.0 is ISPE’s roadmap for pharmaceutical companies to also […]

Aug 26, 2022

Using Real Time Monitoring Systems in the Semiconductor Industry to Increase Product Yield

Jul 27, 2022

Cleanroom Monitoring Explained ; How, when, and why do we do the monitoring in cleanrooms?

Jul 13, 2022

Basics On Minimizing Contamination Risk In Your Cleanroom

What is the biggest villain in the contamination control and cleanroom world? Particles. Contamination. This contamination can cause yield and financial loss, delays, frustration, and physical threats to the end user. It is something that should be avoided wherever possible.  To minimize contamination risk in your cleanroom, you first need to understand what contamination control […]

Jul 1, 2022

Using RTMS To Improve Semiconductor Product Yields

Jun 30, 2022

What is 21CFR11 and why is it so important in maintaining Data Integrity?

Jun 29, 2022

Questions to Ask About The Application of 21 CFR Part 11 In Your Operations

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 requirements of this FDA code in order toenable Data Integrity and Data Traceability as well as the electronic signatures that verify the dataas original, valid, and accurate

Jun 16, 2022

21 CFR part 11 Overview

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 handwritten signatures executed on paper. 21 CFR Part 11 has 10 chapters over 3 subsections. These subsections are General Provisions, Electronic Records, and Electronic Signatures.

Jun 3, 2022

Lighthouse Apex Particle Counters compatibility with Vaporized Hydrogen Peroxide

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 cause deterioration and breakdown of equipment. Due to the nature of theindustries in which it is used, VHP is often used to sterilize equipment while the cleanroomis in use. Thus, […]

May 18, 2022

Fill the “GAP” Good Application Practice “How to Test HEPA Filters ”

Apr 21, 2022

Best Practices in Particle Counter Management To Increase Data Integrity Reliability

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 in regulated industries. Particle Counters should be calibrated regularly based on their use. Manufacturers recommend that Particle Counters are calibrated at a minimum on an annual basis.

Mar 23, 2022

Good Application Practice: How to Perform Proper Cleanroom Classification

Feb 23, 2022

Water For injection Liquid Monitoring for Pharmaceuticals

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. Control of the quality of water, in particular the microbiological quality, is a major concern and the pharmaceutical industry devotes considerable resources to the development and maintenance of water purification […]

Pharma 4.0
Feb 8, 2022

6 Water Purification Methods For Cleanrooms

Water. It makes up 70% of our bodies, but, even more importantly, it serves as a vital ingredient and manufacturing component in cleanrooms. Before we are able to introduce it into the cleanroom setting – especially as part of the product, such as in injectables and other pharmaceuticals – it needs to be purified. We’ve […]

Feb 2, 2022

USP 788 Testing for Particles in Injectable Products

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. Here, particulate matter refers to the small, sub visible particles. The United States Pharmacopoeia, USP <788> provides two tests for detecting such particulates: light obscuration and microscopic assay. Both are […]

Jan 9, 2022

Building Management Systems (BMS), Environmental Management Systems (EMS), and GMP Requirements

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 system (BAS), is a computer-based control system installed in buildings that controls and monitors the building’s mechanical and electrical equipment such as ventilation, lighting, power systems, fire systems, and security […]