Consulting
• On-Site Audits
• Contamination Risk
• Microbial Assessment
• Viral Clearance Reports (Products & Process)
• Contamination Control Troubleshooting
• Protocol Development
COVID-19 Reopening
• Mandatory Safety Standards
• Control Plan Template
• Hygiene Protocol
• Employee Training
• Cleaning Protocol
• Disinfectant Efficacy
• Process Viral Clearance Assessment Reports
Cleanrooms
•Design/Build
• Install Verification
• Operational Qualification
• Performance Validation
• ISO 14644 Certification
• Validation/Commissioning
• Environmental Monitoring
• Smoke Testing/Air Pattern Analysis
•Design/Build
• Install Verification
• Operational Qualification
• Performance Validation
• ISO 14644 Certification
• Validation/Commissioning
• Environmental Monitoring
• Smoke Testing/Air Pattern Analysis
Laboratory Assessments
• Test Services Capability
• Market Analysis
• Quality/Regulatory Audits
• Test Services Capability
• Market Analysis
• Quality/Regulatory Audits
Pharmacy
• USP <797> Compliance
• USP <800> Compliance
• USP <823> Compliance
• 503A/503B Assessments
• Proficiency Testing
• Educational Seminars
• Environmental Monitoring Programs
• New 797 Revisions
• ISO 14644 Certification
• Automated Compounding Device (ACD) Validation
• Shelf Life Extension Studies
• High Risk CSP’s
• USP <71> Sterility
• Endotoxin
• Robotic Pharmacy
• GPO Contracts
• USP <797> Compliance
• USP <800> Compliance
• USP <823> Compliance
• 503A/503B Assessments
• Proficiency Testing
• Educational Seminars
• Environmental Monitoring Programs
• New 797 Revisions
• ISO 14644 Certification
• Automated Compounding Device (ACD) Validation
• Shelf Life Extension Studies
• High Risk CSP’s
• USP <71> Sterility
• Endotoxin
• Robotic Pharmacy
• GPO Contracts
Environmental Monitoring (E/M)
• Compliance Assessments
• Sampling Maps / E/M SOP’s
• Failure Mode Effectivity Analysis (FMEA)
• Trending Programs & Graphical Interface
• USP <1116> Compliance & Implementation
• On-Site Testing (3rd Party)
• Laboratory Analysis (3rd Party)
• Microbial ID’s (3rd Party)
• Objectionable Organism Pathogenicity Reports
• Compliance Assessments
• Sampling Maps / E/M SOP’s
• Failure Mode Effectivity Analysis (FMEA)
• Trending Programs & Graphical Interface
• USP <1116> Compliance & Implementation
• On-Site Testing (3rd Party)
• Laboratory Analysis (3rd Party)
• Microbial ID’s (3rd Party)
• Objectionable Organism Pathogenicity Reports
Therapeutics/Device
• Autologics Products
o T Cell Enhancements (CART)
o Cancer o Vaccines
o Serum Therapy
o Stem Cells
• Imaging Agents
o PET’s
o USP <823> Compliance
o Ultrasonic
• Viral Vectors
o Adeno, Herpes, HIV Carriers
o Vaccines
• Tissue Engineering
o Cell Banks (Master & Working)
o Viral Testing (Donor & Material)
o Feed Processing Validation
o Shelf-Life Studies
o Viral Clearance Studies
o Transport Validation
• Drug/Device Implants
o Diabetes, Osteoarthritis, Pain Management, Chronic Conditions
o Delivery Validation
• 3D Printable Devices
o Orthopedics
o Cranial
o Surgical
• Parenterals
o Most Types Including Syringes, Vials, Bags, etc.
o Sterility/Endotoxin Testing
o Container/Closure Integrity
o Fill/Finish/Closed System Automation
o Ophthalmics
o Vaccines
o Infusions
o Monoclonals
• Autologics Products
o T Cell Enhancements (CART)
o Cancer o Vaccines
o Serum Therapy
o Stem Cells
• Imaging Agents
o PET’s
o USP <823> Compliance
o Ultrasonic
• Viral Vectors
o Adeno, Herpes, HIV Carriers
o Vaccines
• Tissue Engineering
o Cell Banks (Master & Working)
o Viral Testing (Donor & Material)
o Feed Processing Validation
o Shelf-Life Studies
o Viral Clearance Studies
o Transport Validation
• Drug/Device Implants
o Diabetes, Osteoarthritis, Pain Management, Chronic Conditions
o Delivery Validation
• 3D Printable Devices
o Orthopedics
o Cranial
o Surgical
• Parenterals
o Most Types Including Syringes, Vials, Bags, etc.
o Sterility/Endotoxin Testing
o Container/Closure Integrity
o Fill/Finish/Closed System Automation
o Ophthalmics
o Vaccines
o Infusions
o Monoclonals
Non Sterile Pharmaceutical/Nutraceutical/& Cosmetic Products
• microbiology testing assessments USP <61,62>, USP<51>
Education & Training
• Seminars
o Web Presentations
o On-Site Hands-On Training
o Educational Booklets / CEU Testing /Understanding Attestments
• Proficiency Testing
o Aseptic Processing
o Gowning o Cleaning & Disinfection
o Gloving (797)
o GMP/GLP
o Environmental Monitoring
o USP Micro Testing (61, 62, 71, 85, 1116)
o HACCP & Food Safety
o USP <797>
o Preservative Effectiveness (Cosmetics)
• Seminars
o Web Presentations
o On-Site Hands-On Training
o Educational Booklets / CEU Testing /Understanding Attestments
• Proficiency Testing
o Aseptic Processing
o Gowning o Cleaning & Disinfection
o Gloving (797)
o GMP/GLP
o Environmental Monitoring
o USP Micro Testing (61, 62, 71, 85, 1116)
o HACCP & Food Safety
o USP <797>
o Preservative Effectiveness (Cosmetics)
Cleaning & Disinfection
• Pre & Post Cleaning Effectiveness Testing
• On-Site Cleaning Assessments & Audits
• Cleaning SOP’s
• E/M Testing
• “Difficult to Clean Areas” Procedures
• Disinfectant Efficacy Studies
• Contact Time Analysis
• Troubleshooting
• Coronavirus Effectiveness
• Sproricidal / Virucidal Capability Studies
• Training Programs
• Equipment / Process Recommendations
• Pre & Post Cleaning Effectiveness Testing
• On-Site Cleaning Assessments & Audits
• Cleaning SOP’s
• E/M Testing
• “Difficult to Clean Areas” Procedures
• Disinfectant Efficacy Studies
• Contact Time Analysis
• Troubleshooting
• Coronavirus Effectiveness
• Sproricidal / Virucidal Capability Studies
• Training Programs
• Equipment / Process Recommendations
Food & Bakery
• Food Safety Programs
o Training / Educational
• HACCP Program Assessments or
Development
• Critical Control Point Validation
• American Institute of Baking Standards
• Antibiotic Testing of Milk
• Dairy Product (ADPI)
• Pest Control Assessment
• Laboratory Audits (Microbiology)
Garments
• Sterile Garments
o ISO 11137 Gamma Validation
o ISO 11135 EO Validation
o Environmental Monitoring
Testing
o Cleanroom Process Assessment
o Sterility Testing
o Endotoxin Testing
o Biological Indicator Testing
o Sterile Goggles
• Nuclear Garments
o Laundry Assessments
o Respirator Cleaning
o Microbial Disinfection
• Food Processing Garments
o HACCP Programs
o E/M Testing
Miscellaneous
• Microbial Contamination Risk Analysis
• Robotic / Automation Assessments for
Contamination Control
• Fiduciary Support (Labs / Pharmacy /
Biotech / Hospitals)
o Technology Assessment
o Quality / Regulatory Compliance
• Invention / Patent Support Testing
• Architectural Support (Cleanroom /
Pharmacies / Laboratories)
• Group Purchasing Organizations (GPO)
