How can pharmaceutical cleanrooms ensure compliance between certification visits if they don’t have centralized airflow monitoring? Some existing pharmaceutical cleanrooms were designed without centralized monitoring systems. For these facility managers, certification is their primary means of ensuring compliance. It would be ideal, however, to know when intervention may be necessary during daily operations. The big […]
Renovating or Building a Cleanroom? What to do and What to Avoid
Whether you’re renovating or building a cleanroom, there are numerous factors that come into play. Without the right planning and preparation, your cleanroom build can be a headache at best and a disaster at worst. The purpose of your cleanroom and your unique facility are individual to you, so do your homework. Here is a […]
Testing Compressed Air Lines – Medical Device Manufacturing
If you’re a medical device manufacturer, you need to clean the air systems that clean your components. Here is some advice. Compressed air is used in many applications for medical device manufacturers. While they are generally used to eliminate contaminates, the compressed air system itself can harbor microorganisms. This can adversely affect the product, so […]
Quick Checklist for Cleanroom Cleaning Costs
Here’s a checklist for your cleanroom cleaning system costs. Use this as a guideline for budgeting with your new system. We post a lot of information about cleaning your cleanroom. It is a complex and involved aspect of compliance and safety. Things to consider vary from the cleanroom itself to the parts inside of it. […]
Three Tests for Disinfectants for Cleanroom Validation
You need to control fungal contamination in your cleanroom, and you need to test the disinfectants for validation. Here are three to consider. Controlling fungal contamination in your cleanroom requires cleaning and disinfection procedures. Your disinfectant application is a critical step that needs validation. Since many agents that are effective against vegetative fungi aren’t effective […]
Methods for Testing Container Closure Integrity: Cleanroom Products – Part 1
There are a number of alternative methods to test container closer integrity for drug products. Start comparing these methods here. Container closure integrity (CCI) of a drug product must be preserved throughout its entire shelf life. There are a number of ways to conduct a CCI test, each with its pros and cons. Here is […]
3 Ways to Sterilize Cleanroom Apparel
Sterility is a major part of every cleanroom, be it the equipment, the tools, the product, or the structure. In aseptic cleanrooms, the garments must also be sterile. Most companies require all components in an aseptic cleanroom – including garments – to be terminally sterilized to 10-6SAL. There are three methods of achieving this: autoclaving, […]
Why Small Particles Stick – Clean the Cleanroom
We all know that the smaller the particle, the harder it is to clean. They always get stuck in those tiny, hard-to-reach spaces. Here’s why. Dispersion forces. They make a gecko’s feet stick to walls. They also make small particles get stuck in really tiny places and cause them to be so hard to clean. […]
Cleaning the Components in Electronics Manufacturing
Electronic components in adverse environments require careful cleaning to remain compliant. This article explores the means of doing so. Thanks to no-clean fluxes and soldering pastes, the need to clean components in electronics manufacturing has decreased significantly. However, this is only the case for components used in non-critical atmospheric environments. Adverse environments, like humid […]
Continuous Availability: Disaster Planning for your Controlled Environment
If you have critical data in your facility, you need to ensure it’s protected in the face of disaster. Here is a guideline on how. Whether it’s manmade or natural, many manufacturers with cleanroom facilities are vulnerable to disaster. Three main concerns should this occur are security, risk management, and business continuity. Should any of […]