Business Details
30 Years
experience
Emergency
services
Expert Cleanroom Cleaning & Contamination Control Services
Cleantech Systems has been a leader in precision cleanroom cleaning, disinfection, and decontamination since 1996. Our team specializes in removing contamination variables that cause product loss or manufacturing downtime, adhering strictly to federal regulations and international cleanroom standards. With over 30 years of expertise, we function as a strategic partner to clients in medical device, pharmaceutical, biotech, nanotech, semiconductor, and aerospace industries. Our approach includes careful hiring, in-depth training, steady service delivery, and collaboration to ensure compliance with ISO, IEST, and FDA requirements.We maintain detailed documentation, employ triple-screened technicians fluent in English, and provide consistent, auditable processes that have earned us a loyal customer base. Our proven track record includes successful aseptic validation support and contamination control programs for Fortune 100 companies and academic institutions.
Services
Cleanroom Cleaning
Disinfection Services
GAP Analysis Audits
SOP Writing
Technical Training
Emergency Disinfecting
HVAC System Evaluation
Facility Validation
Details
- Year established: 1996
Highlights and features
- 30+ years of cleanroom contamination control expertise
- 100% FDA audit compliant and ISO certified operations
- Triple-screened, English-fluent technicians with low turnover
- Proven success with Fortune 100 and academic institution clients
- Customized contamination control programs with detailed documentation
What people say
Excellent and consistent work
Highly knowledgeable leadership
Thorough contamination control programs
Successful aseptic validation support
Low employee turnover
Services
Cleanroom Cleaning
Daily cleanroom cleaning and disinfection services following ISO 14644-5 standards. Our trained technicians use validated methods to maintain contamination control in regulated environments. Services include surface cleaning, HEPA filter maintenance, and material handling protocols to protect critical manufacturing processes.
GAP Analysis Audits
Comprehensive contamination control assessments identifying facility integrity issues and operational deficiencies. Our audits follow ISO and IEST standards, evaluating HVAC systems, contamination sources, and personnel practices. Recommendations focus on improving compliance and reducing product loss risks through targeted corrective actions.
SOP Development
Customized standard operating procedure development for cleanroom operations. Our documentation specialists create clear, compliant instructions aligned with cGMP requirements. All SOPs undergo client review and incorporate industry best practices for contamination control and regulatory compliance.
Technical Training
Ten-step modular training program covering cleanroom fundamentals, contamination risks, and proper cleaning techniques. Includes classroom instruction, on-the-job training, and annual re-certification. Training records are maintained for audit readiness and client verification purposes.
Emergency Disinfecting
Rapid-response disinfection services for contamination incidents and pandemic situations. Our team implements validated protocols for pathogen elimination while maintaining cleanroom integrity. Services include post-construction cleaning and remediation of unexpected contamination events in controlled environments.
People
Ian Wallis
Director of Quality Assurance
30+ years of cleanroom contamination control expertise. Leads quality systems and GMP account management. Conducts expert witness work and has started over 200 cleanroom accounts across multiple industries while maintaining regulatory compliance.
Dighero Krische
Operations Director
Co-founder with 30 years of cleanroom operations experience. Manages daily operations and maintains high client retention through effective management practices and commitment to service excellence in controlled environment cleaning.
Mark F. McGinn
Sales & Customer Service Manager
20-year CleanTech veteran with direct cleanroom experience. Manages customer relationships and technical training production. Recognized for responsive service in ISO 7 cleanroom environments and client satisfaction.
Kenneth S. Weinberg
Cleanroom Environmental Scientist
Ph.D. environmental scientist advising on safety and contamination control. Former Director of Safety at Massachusetts General Hospital. Develops safety protocols and trains staff on OSHA compliance and contamination prevention measures.
Questions
What industries do you serve?
We specialize in medical device, pharmaceutical, biotech, semiconductor, aerospace, and nanotechnology cleanroom environments.
Are your technicians certified?
All technicians undergo triple-screening, ADP background checks, and complete our 10-step modular training program with annual re-certification.
How do you ensure regulatory compliance?
We maintain 100% FDA audit compliance and ISO standards through detailed documentation, validated cleaning processes, and regular quality assessments.
Can you handle emergency situations?
Yes, we provide emergency COVID-19 disinfecting services and rapid response for contamination incidents.
What's included in your GAP analysis?
Our audit evaluates facility integrity, HVAC systems, contamination sources, and operational practices against ISO 14644 and IEST standards.
Do you provide documentation support?
We offer comprehensive SOP writing services and maintain detailed records available for client review at any time.
