Quality Solutions
Quality Solutions, LLC is a provider of compliance and support services for the biotech, healthcare, and pharmaceutical industries. Established in 2001, the company offers a comprehensive portfolio of services including validation, facility design, environmental monitoring, USP<797>/<800> compliance, decontamination, and personnel training. Committed to long-term relationships, quality, and cost-effectiveness, they support clients in developing, implementing, and maintaining quality and compliance programs, reducing operational delays, and ensuring regulatory adherence.
Industries
Nr. of Employees
small (1-50)
Quality Solutions
Products
Environmental Monitoring Kit (subscription)
A subscription-based kit containing calibrated monitoring equipment, consumables, sampling plates, labels, instructions and return shipping for laboratory incubation and reporting to support routine environmental monitoring.
Chemo Wipe Testing Kit (semi-annual)
Kit for surface wipe sampling of hazardous drugs, including consumables, deionized water, labels, instructions and return shipping for laboratory analysis of selected chemotherapy agents.
Environmental Monitoring Kit (subscription)
A subscription-based kit containing calibrated monitoring equipment, consumables, sampling plates, labels, instructions and return shipping for laboratory incubation and reporting to support routine environmental monitoring.
Chemo Wipe Testing Kit (semi-annual)
Kit for surface wipe sampling of hazardous drugs, including consumables, deionized water, labels, instructions and return shipping for laboratory analysis of selected chemotherapy agents.
Services
On-site execution of USP-compliant microbiological air and surface monitoring, non-viable particle counts, differential pressure testing, and lab analysis.
Certification and re-certification of biological safety cabinets, laminar flow hoods, compounding isolators and cleanroom spaces including HEPA testing and particle counts.
Design qualification, construction management, equipment selection and commissioning support to incorporate quality and CGMP compliance into facility projects.
Equipment, facility and process validation including IQ/OQ/PQ, HVAC and cleanroom systems, sterilization/cleaning validation, and shipping/packaging validation studies.
Surface wipe sampling and laboratory analysis for hazardous drug residues to verify containment strategies and compliance with hazardous drug handling guidelines.
Training programs, competency assessments, media-fill and glove fingertip assessments, and train-the-trainer services focused on aseptic practices and USP compliance.
On-site execution of USP-compliant microbiological air and surface monitoring, non-viable particle counts, differential pressure testing, and lab analysis.
Certification and re-certification of biological safety cabinets, laminar flow hoods, compounding isolators and cleanroom spaces including HEPA testing and particle counts.
Design qualification, construction management, equipment selection and commissioning support to incorporate quality and CGMP compliance into facility projects.
Equipment, facility and process validation including IQ/OQ/PQ, HVAC and cleanroom systems, sterilization/cleaning validation, and shipping/packaging validation studies.
Surface wipe sampling and laboratory analysis for hazardous drug residues to verify containment strategies and compliance with hazardous drug handling guidelines.
Training programs, competency assessments, media-fill and glove fingertip assessments, and train-the-trainer services focused on aseptic practices and USP compliance.
Expertise Areas
- Cleanroom certification and qualification
- Environmental monitoring program development
- USP <797>/<800> compliance and gap analysis
- Microbiological testing and identification
Key Technologies
- Viable air sampling
- Non-viable particle counting
- Air impaction samplers
- HEPA filter challenge and leak testing