The Electronics Manufacturing, Medical Device, Aerospace, and Defense Industries The function of thermal interface materials is to fill the gaps between heat-generating components and heat
This article defines, contracts, and compares FDA and EPA requirements for the efficacy of various chemical germicides, sterilants, and disinfectant chemicals.
The ideal cleanroom wipe must meet industrial and regulatory standards concerning chemical, physical, and biological compatibility. Wipe fabrics undergo a strict examination to simulate manufacturing outcomes in the real world.
Stretch and strength, chemical compatibility, task efficiency, sorbency, shed, retention, and biological harmony have unique consequences in both high-tech cleanrooms and general manufacturing floors.
Facilities often choose PAC for cleanroom construction services because our vendor and manufacturing networks are not limited to any single brand-specific solution. PAC cleanroom expertise in your back pockets helps you overcome preliminary engineering challenges and consolidate your project management to a single point of contact.
What are the steps for medical device cleanroom validation? Cleanroom validation ensures cleanroom construction meets the performance standards set forth during cleanroom planning, cleanroom installation, and cleanroom calibration.
Here we’ll cover advantages of stereo inspection microscopes for stem cell and cellular biology use. Specifically, you’ll learn about advantages of more robust eyepiecesless microscope
The central controller integrates the data from both the thermostats, fan filter processors, and room-side environmental sensors. Fan filter speed is then adjust by each group to achieve the specified room pressure while at ideal temperature and humidity.
Before cleanroom validation, a cleanroom requires mechanical calibration. HVAC calibration first ensures that the room meets the performance parameters which would deliver the expected results during final ISO validation, such as differential pressure, air change rates, and uniform airflow distribution.
In this post, we overview technical considerations for clean room fan filter unit selection, installation, and features. You’ll learn how PAC approaches design and configuration
In medical device cleanrooms, a common configuration is an ISO 8 gowning room and ISO 7 primary production area. A cascading air flow design and
How is a medical device cleanroom built? Here’s a component-by-component guide to ISO Class 7 cleanroom construction.
Based on message receipts from internal FDA communications, readers get a glimpse into the high stakes, bizarre, heroic, tragic, and even comical ways that overseas drug manufacturers dupe the FDA (or at least attempt to).
While most large scale production facilities have standardized manufacturing controls, those mixing liquids in small facilities without environmental controls may struggle to receive pre-market approval.
3D printers are known to produce a number of byproducts during operation. Common 3D printing filaments such as ABS and PLA are known as high emitters of ultra-fine particulates (UFPs), while nylon and PCTPE are known for high levels of volatile organic compounds (VOC) concentrations. Once airborne, particles and noxious fumes are easily absorbed into the lungs where they can enter tissues and cells.
What Kind of Cleanroom Do I Need for a Class II Medical Device? What About Class III? This post classifies medical device cleanrooms for manufacturing and packaging.
Expansion creates unforeseen complexities and challenges within supply chains. Communication breakdowns, competing priorities, and distraction from core competencies interrupt economies of scale. Valuable manufacturing space gets converted into storage space, order minimums become bloated, inventory swells, and eventually, quality and delivery times suffer.
What are the advantages of peracetic acid sterilants for cleanroom disinfection? Where is it used? How does it compare to gas sterilization methods?
Our friends at Simco-Ion sent us this brilliant guide to ESD cleanrooms design, principles, and other considerations. Download the PDF you’ll find case studies and technical information about how static charges influence particle retention and impact manufacturing outcomes in controlled environments. Below we’ve highlighted important ideas in relation to medical device cleanrooms and provide additional resources.
Does a HEPA filter capture ultrafine particles (UFPs). What toxins does 3D printing produce? Why should every 3D printer have both a activated carbon and HEPA filter?
M+A Matting produces an advanced version of the wiper mat called the Microluxx™. The surface excels at trapping and absorbing high levels of debris and moisture, retaining 2.5x more moisture than standard carpeted mats.
