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
Hunt Valley, Maryland, United States, North America
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 environmental monitoring and testing
On-site execution of USP-compliant microbiological air and surface monitoring, non-viable particle counts, differential pressure testing, and lab analysis.
Cleanroom and PEC certification
Certification and re-certification of biological safety cabinets, laminar flow hoods, compounding isolators and cleanroom spaces including HEPA testing and particle counts.
Facility design and engineering support
Design qualification, construction management, equipment selection and commissioning support to incorporate quality and CGMP compliance into facility projects.
Validation and qualification services
Equipment, facility and process validation including IQ/OQ/PQ, HVAC and cleanroom systems, sterilization/cleaning validation, and shipping/packaging validation studies.
On-site chemo wipe testing and analysis
Surface wipe sampling and laboratory analysis for hazardous drug residues to verify containment strategies and compliance with hazardous drug handling guidelines.
Personnel training and competency assessment
Training programs, competency assessments, media-fill and glove fingertip assessments, and train-the-trainer services focused on aseptic practices and USP compliance.
On-site environmental monitoring and testing
On-site execution of USP-compliant microbiological air and surface monitoring, non-viable particle counts, differential pressure testing, and lab analysis.
Cleanroom and PEC certification
Certification and re-certification of biological safety cabinets, laminar flow hoods, compounding isolators and cleanroom spaces including HEPA testing and particle counts.
Facility design and engineering support
Design qualification, construction management, equipment selection and commissioning support to incorporate quality and CGMP compliance into facility projects.
Validation and qualification services
Equipment, facility and process validation including IQ/OQ/PQ, HVAC and cleanroom systems, sterilization/cleaning validation, and shipping/packaging validation studies.
On-site chemo wipe testing and analysis
Surface wipe sampling and laboratory analysis for hazardous drug residues to verify containment strategies and compliance with hazardous drug handling guidelines.
Personnel training and competency assessment
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