Cleanrooms are carefully controlled environments that need to be as free from external contamination as possible. These rooms require best practices to manufacture or GMP. G-Con Manufacturing follows ISO and OHSAS standards to create quality, low-cost, fabricated cGMP cleanrooms.
What standards govern manufacturing?
ISO and OHSAS provide guidelines for construction and fabrication. Cleanroom maintenance falls well within the requirements provided by these organizations.
Construction of these environments is itself a process. Requirements are gathered, materials purchased, the room built, and testing occurs to ensure adequate functionality. ISO and OHSAS create standards for technical projects.
What components can fail in a cleanroom?
Air filtration, ports of entry, and welds work in conjunction to ensure that your environment remains contamination free. If a stress fracture occurs or your system fails to detect the appearance of external contaminants, your process or even your patients are at risk.
Filtration and air circulation systems are among the most important pieces to the construction off any cleanroom. When these parts fail anyone within the room is at risk as these pods are meant to be completely airtight. Therefore, it is important that detection systems remain active.
ISO 45001 and ISO 9001
ISO is an internationally recognized organization specifically related to the quality of technical products and services. Their standards are quickly replacing those from country-specific organizations such as the OSHAS.
Cleanrooms require software to regulate the environment and are intricately designed with skilled workforces providing the best-finished products. We follow ISO 9001 standards on project management and ISO 45001 for workplace safety. Both are certifiable and we take pride in continuing to hold relevant ISO approvals.
To ensure that our standards hold the world over, we also follow OHSAS 18001. Organizations adhering to these standards, replaced by ISO 45001 in 2021, exhibit a commitment to workplace safety. G-Con Manufacturing believes that a healthy workforce makes skilled craftsmanship a priority. Rather than racing to finish our cleanrooms, we retain an environment promoting pride.
Why should an organization adhere to best practices?
Clean room design backs some of the most important industries in the country. Electronics such as semiconductors and pharmaceuticals need sterile environments to produce sensitive and health-altering goods.
Best practices from ISO allow organizations to retain a standard of quality that avoids potential disaster. Our sensor and filtering software, materials, design process, fabrication, and installation are carefully built to ensure success.
GCMP Cleanroom Manufacturer in Texas
G-Con Manufacturing uses best practices in the creation of cleanrooms. We work with clients from design through testing, helping you save money with well-designed processes and a product proven to work. Our commitment to our staff allows us to retain skilled craftspeople dedicated to the success of every project.
Our commitment to the standards proven to limit overruns and promote satisfaction is the reason we are an award-winning company. We received recognition for our cleanrooms only three short years after starting and continue to be a leader in the industry with a 2019 Pharma Innovation Awards award.
Get in touch with one of our project managers today.