Feb 2, 2024

Going Paperless in the Cleanroom

Dec 26, 2023

Establishing a PHARMA Environmental Monitoring Program

Dec 26, 2023

The Basics of Liquid Particle Counting

Dec 26, 2023

Understanding 4-20mA Data Accuracy in Particle Counting

Dec 26, 2023

Cleanroom Gowning

Dec 26, 2023

Cleanroom Grades A,B,C,D Explained

Dec 26, 2023

Cleanroom Air Changes

Dec 26, 2023

The Impact of Low Counting Efficiency Explained

Dec 21, 2023

Cleaning & Wipedown

Dec 20, 2023

Going Paperless in the Cleanroom with the ApexZ Portable Particle Counter

Dec 20, 2023

Types of Contamination

Nov 14, 2023

PARTICLE COUNTING SAMPLE TUBING GUIDANCE AND BEST PRACTICES

Nov 14, 2023

HOW TO PERFORM A PQ ON A PARTICLE MONITORING SYSTEM

Nov 14, 2023

Manifold Monitoring Systems Explained

Nov 13, 2023

MTBF of LWS Particle Counters

Nov 2, 2023

USP 797 AND ITS IMPLEMENTATION IN ASEPTIC COMPOUNDING ENVIRONMENTS

Tech Paper - Medical Devices and Environmental Monitoring
Sep 26, 2023

MEDICAL DEVICES AND ENVIRONMENTAL MONITORING

THE DIFFERENCE BETWEEN ZERO COUNTS AND FALSE COUNTS Lighthouse
Sep 15, 2023

USING PARTICLE COUNTERS -THE DIFFERENCE BETWEEN ZERO COUNTS AND FALSE COUNTS

Jul 13, 2023

PARTICLE COUNTERS AND WAFER MANUFACTURING IN A SEMICONDUCTOR CLEANROOM

Jul 6, 2023

OVERVIEW OF COMPOUNDING ASEPTIC PRODUCTS AND MONITORING FOR VIABLE AND NON-VIABLE PARTICLE CONTAMINATION.

Jun 22, 2023

ADVANCEMENTS IN PARTICLE COUNTER BASED TESTING AND MONITORING FOR CLEANROOMS, FILTERS, AND SEPARATIVE DEVICES

Jun 8, 2023

OVERVIEW OF EU GMP ANNEX 1:2022

Nov 22, 2022

Remote Particle Counters For Pharmaceutical Applications

Nov 17, 2022

How to Choose Cleanroom Monitoring Instruments

Nov 10, 2022

Basics Of Particle Counting

Nov 3, 2022

Indoor Air Quality And Its Impact On Our Health And How To Improve It

Oct 13, 2022

How to Gas Sample Using a Particle Counter

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 product process zones in ISO 5 cleanrooms and zones require tight control on contamination and compressed gases used may also if not checked correctly be an avenue for particulate contamination […]

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

GAMP5’s Impact On Developing Monitoring Systems

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 manufacturers and users of automated systems in the pharmaceutical industry. ISPE is the world’s largest not-for-profit association serving its members by leading scientific, technical and regulatory advancement throughout the entire […]

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 […]

Sep 9, 2022

Performance Quality Testing And Environmental Monitoring

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 operational objectives in a real world operational environment. It is the final step in equipment and systems qualification. A PQ should never be a re-execution of the vendor supplied Operational […]

Jul 1, 2022

Using RTMS To Improve Semiconductor Product Yields

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 8, 2022

Lighthouse Active Air Sampler Technology and d50

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 a critical role in air sample capture. Aerosol Impaction is the process in which particles are removed from an air stream by forcing the gases to make a sharp bend. […]

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 27, 2022

The Selection of the right Air Sampling Equipment for Your Process and Quality Assurance

May 19, 2022

Cleanrooms Explained

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 process and product. The main components of a cleanroom are what keeps the cleanroom clean. To control contamination in a cleanroom clean air is required, access is limited and outside […]

May 4, 2022

Cleanroom Air Filters: Controlling Contamination in The Cleanroom

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 control of temperature/humidity, pressure and particles are essential for optimum operational performance.

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.

Apr 1, 2022

Airborne Particle Counters and How They Work

Mar 14, 2022

Particle Count Cleanroom Certification versus Routine Particle Monitoring and current GMP requirements

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 tested using a Portable Particle Counter sampling at a defined volume at evenly spaced test locations around the cleanroom based on current Cleanroom Standards. The most accepted and widely used […]

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 […]

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 […]

Jan 1, 2021

Integrating ApexZ with LMS Pharma8

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 following topics: 1. Establishing a connection to the ApexZ unit via the Configuration Tool 2. Establishing a connected unit into LMS Pharma’s Database Tree 3. Adding a connected unit to […]

Aug 15, 2016

ApexR5 Remote Particle Counter-Addressing Risks in Airborne Particle Counting

Oct 1, 2015

Airborne Particle Deposition in Cleanrooms

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 and electronstatic attraction can also occur at all particle sizes, and for particles below 0.5 µm Brownian diffusion is important.