Posts tagged 'GMP'
We are working hard to get caught up and new batch's are in progress. The team has worked 8 weeks straight 7 days a week to keep up with orders and finish the cleanroom move. We have applied to be a AKA approved vendor and it is in progress. We have an ISO classification testing scheduled which our production and isolation room will be an ISO 7 and gowning ISO 8.
Manufacturing supplements does not require a certified ISO rating just a "cleanroom" with industry standards. We wanted to take it a step further and built ours to be able to show and document to our customers it has been inspected and certified by a 3rd party. Customer safety and our transparency to show our customers we are truly serious about being a leading vendor in this industry.
ISO Classifications are 1-8. They are a critical factor in cleanroom design.
An important design feature is controlling air-change per hour (ACH), also known as the air-change rate, or ACR. This refers to the number of times each hour that filtered outside air replaces the existing volume in a building or chamber. In a normal home, an air-conditioner changes room air 0.5 to 2 times per hour. In a cleanroom, depending on classification and usage, air change occurs anywhere from 10 to more than 600 times an hour.
Achieving the optimal air change rate requires proper ceiling
fan coverage. The cleanest modular cleanroom
incorporates filter/fan units (FFUs) in every 2’ x 4’ (610 mm x 1219 mm) ceiling bay. This near-100% coverage provides a laminar flow of filtered air to quickly remove contaminants from the room, thus meeting FS209E standards for Class 10 and ISO Class 1 standards.
Our cleanroom is positive pressure.
What is positive pressure?
Positive Pressure Cleanrooms are designed to maintain positive pressure, preventing "unclean" (contaminated) air from flowing inside and less-clean air from flowing into clean areas. The idea is to ensure that filtered air always flows from cleanest to less-clean spaces. So inside the cleanroom air flow is restricted to just a few small vents. Only purified air is introduced from special Hepa filters that are 99.9999% rated.
An ISO 7, 15-25% of the ceiling is filter units.
Contact surfaces and equipment are all stainless steel making them easy to clean and they won't support bacteria growth. We also do random microbial testing on contact surfaces on site. Keep an eye on our blog for more updates and info