Our Experts Can Help You To:
• Prevent Product Loss
• Perform Gap Analysis
• Write SOP Documents
• Prepare for FDA Inspections
• Achieve Aseptic Validation
• Comply with ISO/IEST
Our Experts Can Help You To:
Prevent Product Loss • Perform Gap Analysis • Write SOP Documents
Prepare for FDA Inspections • Achieve Aseptic Validation • Comply with ISO/IEST
Partner – Director Of Quality Assurance
I have led teams that have started up over 200 cleanroom manufacturing customers, solving non-compliant cleanroom contamination problems for pharmaceutical, biotech, aerospace, semiconductor and medical device industries. I have been an expert witness, investigator, GAP Analysis Auditor, educator & trainer on many clean-technology related subject matters.
We have provided contamination control auditing, defect investigations, technical instruction, FDA response team participation, training, and benchmarking to all cleanroom manufacturing sectors.
We have participated in many FDA and international regulatory audits, managed forensic analysis down to the level of compounds and elements, been an expert witness in the New England Compounding Lab tragedy, and helped to create standardization of cleaning and disinfection methods.
Our Technical Services
Rooted in Federal Regulations & International Cleanroom Standards
1. Quality Audit: Our GAP Analysis audit identifies deficiencies in facility integrity, personnel and operational practices. Identify contamination sources, transmission and transportation routes. Suggest corrective actions.
2. SOP Writing: Customized instructions for precision performance. All documents written with an eye toward clarity and consistency.
• Thorough and effective cleanroom and contamination control training for employees and vendors.
• Training Program Creation that is customized and highly effective.
We are respectful of your team, supporting their professional capacities, while working to resolve non-compliance situations.
“Ian is a highly knowledgeable, effective and competent leader in managing the risk of cleanroom contamination.”
“Ian performed a critical quality audit for us and then engineered a cleaning and disinfection program for our new Cell Culture facility in Framingham, MA. He was also instrumental in writing a state-of-the-art Cleaning and Disinfection SOP rooted in cGMP’s and ISO 14644 -5 Cleanroom Operations, contamination control standards.”
Dighero Krische (DK)
co-founder and Operations Director of CleanTech
Mark F. McGinn
Sales & Customer Service Manager
Kenneth S. Weinberg, Ph.D.
Cleanroom Environmental Scientist
Dr. Weinberg has held positions as the Director of Safety at Massachusetts General Hospital in Boston and as an Industrial Hygienist at the Brockton/West Roxbury Veterans Administration Hospital.
“CleanTech Systems has been cleaning with us since we opened in July of 2007. Their crew is knowledgeable and highly reliable.”
– Noah Clay, Nanofabrication Manager, Center for Nanoscale Systems, Harvard University