
GCA Critical Environment Cleaning Services (GCA-CE) cleans and disinfects cleanroom space for clients throughout the U.S. and Puerto Rico. GCA-CE is purpose-driven and expresses it daily by:
- Protecting personnel against unwanted contamination
- Protecting and improving customer product and process quality
- Strict adherence to cGMP practices and techniques, Institute of Environmental Sciences and Technology (IEST) Federal Standards, and ISO Cleanroom Operations Standards where appropriate
- Removing the cleanroom facility surfaces as one of the contamination variables that negatively effects our customers' products and processes
GCA-CE approaches contamination control not as a janitorial function, but rather as a science and technology that continuously interacts with all product, process and personnel.
GCA-CE is run by cleanroom specialists who:
- Are knowledge leaders and editorial consultants for ISO 14644-5 Cleanroom Operations
- Understand cleanrooms and clean manufacturing
- Have vast experience, expertise and proven track record of outstanding service to our customers' critical environments
- Focus on customer product and process protection
- Play a vital role on customer quality team's
- Provide unmatched contamination control employee training
- Have an outstanding safety program
- Practice the strictest screening and hiring standards
- Are Federal Standard's Writers and have a Board Membership with the IEST
- Are members of:
- Institute of Environmental Sciences and Technology (IEST)
- International Society of Pharmaceutical Engineers (ISPE)
- Controlled Environment Testing Association (CETA)
- Parenteral Drug Association (PDA)
- American Biological Safety Association (ABSA)
GCA-CE maintains various types of cleanroom and production environments, including:
- Bio-pharmaceutical
- Semiconductor/Microelectronics
- Aerospace
- Bio-safety
- Chemical
- Defense
- Medical Devices
- Nanotechnology
- Optics
GCA-CE provides the following services:
- Sterile environments (Bio-Pharmaceutical & Bio-containment Labs)
- Engineered cleanroom cleaning programs
- Decontamination and disinfection
- SOP writing – Compliant with cGMP's,
- Contamination control GAP analysis audits
- Gown Room management
- Protocol design, training, and enforcement
- Bio Safety Level 2 & 3
- Lab support services- Depyrogenation, glass wash, autoclaving
- Non-sterile environments
- Engineered cleanroom cleaning programs
- SOP writing – Compliant with federal & international standards
- Engineered cleanroom cleaning programs
- SOP writing – Compliant with federal & international standards
- Clean build & post-construction cleaning
- Contamination control GAP analysis audits
- Gown Room management
- Protocol design, training, and enforcement
- Gown Room management
- Airborne & surface particle testing
- Data center/ESD cleaning
Quality Assurance
GCA-CE's approach to Quality Assurance incorporates personnel, equipment, extensive training and industry expertise to guarantee that our client's facilities meet or exceed the regulations set forth by ISO or by the FDA.
Personnel
All GCA-CE cleanroom technicians are thoroughly screened. We recruit highly motivated, responsible individuals who take pride in the work they do.
Equipment
GCA-CE has formed alliances with the nation's leading suppliers of cleanroom equipment. Highly specialized tools and equipment are selected based on the SOPs of the given environments. GCA extends its substantial national buying power to our clients often resulting in lower overall costs.
Training
All GCA-CE employees are required to complete specific training regimens before entering a critical environment. All technicians are trained on cleanroom protocol, safety, security, cleaning techniques and client specific procedures.
Industry Expertise
GCA-CE's subject matter experts have proven success in cleanroom operations. Our solid reputation and excellent client references speak to our ability to deliver outstanding service in complex environments.
