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Manufacturing Process

Sterile compounding delivering reliability and resiliency

End-to-end, we NEVER sacrifice quality

QuVa uses only FDA-approved, commercially available sterile starting material to compound our sterile-to-sterile products.

From the moment we take delivery of commercially available sterile starting material, to the time our ready-to-administer products arrive at your hospital, we never sacrifice quality.

When there is an identified clinical need, or when a drug is on the FDA Drug Shortages list with commercial sterile starting material being unavailable, QuVa provides you resiliency and reliable supply using API starting material only from suppliers that are FDA approved, have licensed Drug Master Files (DMF), and have been internally qualified for their intended use.

Transparency throughout our processes

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Our process

Incoming material

At the time each item is received, it is reviewed against QuVa’s requirements, and the incoming Certificate Of Analysis (COA) or Certificate Of Conformity (COC).

Prep

The components are prepped and decontaminated with approved and qualified cleaning agents before being moved into our ISO certified clean rooms. Sterile barriers and aseptic techniques safeguard against contamination.

Compounding

Drug compounding is carried out in an environmentally controlled and monitored environment by qualified QuVa professionals. Strict personnel and environmental monitoring is applied for each batch produced to ensure the environment is maintained at all times within the ISO 5 classified space. Monitoring results are recorded as part of our quality control testing reports and required for specific batch release.

Labeling & packaging

QuVa’s proprietary labels help to ensure against medication errors though increased readability, prominent beyond use expiry dates (BUD) and barcoding. QuVa’s labels are 100% compliant with the Drug Safety and Security Act (DQSA) requirements.

Shipping

We use barcode tracking to follow the movement of your product all the way through our facility to delivery at your hospital. Shipping tracking information is emailed to customers as part of each shipment notification.

Staging

The product barcode is scanned and added to our production system. The FDA-approved sterile drug components are transported to the prep area.

Aseptic environment

We use both single use and re-usable gowns and are actually moving to reuseables more in light of the COVID crisis.

Lab testing

Every compounded batch undergoes rigorous quality control testing. We use state-of-the-art technology including Ultra Performance Liquid Chromatography (UPLC) for Potency, BioMerieux Scan RDI for Sterility, and Charles River Endosafe for Endotoxin, as well as traditional methods.

Batch release

Quality Assurance reviews all documentation associated with manufacturing batches, from the materials used through the analytical and microbiological test results. Quality Assurance also reviews all test results for personnel and environmental monitoring to ensure expectations are met and tests conform to QuVa’s specifications for release. A Certificate Of Analysis (COA) is created for each batch. Retention samples are pulled from every batch and stored at QuVa.

Incoming material

At the time each item is received, it is reviewed against QuVa’s requirements, and the incoming Certificate Of Analysis (COA) or Certificate Of Conformity (COC).

Staging

The product barcode is scanned and added to our production system. The FDA-approved sterile drug components are transported to the prep area.

Prep

The components are prepped and decontaminated with approved and qualified cleaning agents before being moved into our ISO certified clean rooms. Sterile barriers and aseptic techniques safeguard against contamination.

Aseptic environment

We use both single use and re-usable gowns and are actually moving to reuseables more in light of the COVID crisis.

Compounding

Drug compounding is carried out in an environmentally controlled and monitored environment by qualified QuVa professionals. Strict personnel and environmental monitoring is applied for each batch produced to ensure the environment is maintained at all times within the ISO 5 classified space. Monitoring results are recorded as part of our quality control testing reports and required for specific batch release.

Lab testing

Every compounded batch undergoes rigorous quality control testing. We use state-of-the-art technology including Ultra Performance Liquid Chromatography (UPLC) for Potency, BioMerieux Scan RDI for Sterility, and Charles River Endosafe for Endotoxin, as well as traditional methods.

Labeling & packaging

QuVa’s proprietary labels help to ensure against medication errors though increased readability, prominent beyond use expiry dates (BUD) and barcoding. QuVa’s labels are 100% compliant with the Drug Safety and Security Act (DQSA) requirements.

Batch release

Quality Assurance reviews all documentation associated with manufacturing batches, from the materials used through the analytical and microbiological test results. Quality Assurance also reviews all test results for personnel and environmental monitoring to ensure expectations are met and tests conform to QuVa’s specifications for release. A Certificate Of Analysis (COA) is created for each batch. Retention samples are pulled from every batch and stored at QuVa.

Shipping

We use barcode tracking to follow the movement of your product all the way through our facility to delivery at your hospital. Shipping tracking information is emailed to customers as part of each shipment notification.

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