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.
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.
There are a few final preparations required before the final cleanroom flooring installation. Here’s what to expect and consider for cleanroom tile installations and flooring installation.
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
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.
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.
Discover solutions for the medtech arena including materials, smart sensors, components, packaging, testing, and cutting edge-products.
Is sterile 3D printing possible? Are 3D printed parts sterile? This comprehensive guide to 3D printing sterile parts provides materials that withstand various sterilization techniques such as autoclaving, heat, ETO, and gamma. Here’s how 3D printing will enhance medical tooling and device manufacturing.
