ICALSG offers high quality and cost-effective complete solution for Riboflavin Coverage Testing service
Riboflavin Coverage Testing
Purpose
To test Clean in Place (CIP) spray patterns in stainless steel process vessels for completeness of spray coverage. The tanks may contain an agitator, vortex breaker, nozzles, man-way, fittings, projections, etc., which could create spray “shadows.” These shadowed areas must all be cleaned.
Scope
The pattern testing of all CIP devices installed in vessels requiring documented proof of cleanability.
Background
A fluorescent dye solution is sprayed on the interior of process tanks and the CIP system cycled to study the spray patterns and cleaning effectiveness.
Compliance
Our Test Service complies to
- 21CFR211.67(b) – Cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding of a drug product.
- 21CFR600.11(b) – Processing and storage containers, filters, filling apparatus, and other pieces of apparatus and accessory equipment, including pipes and tubing, shall be designed and constructed to permit thorough cleaning and, where possible, inspection for cleanliness. All surfaces that come in contact with products shall be clean and free of surface solids, leachable contaminants, and other materials that will hasten the deterioration of the product or otherwise render it less suitable for the intended use.
- VDMA – “Riboflavin test for low-germ or sterile process technologies, Fluorescence test for examination of cleanability for food, aseptic, pharmacy and chemistry”
ICALSG Qualification Certificate
Our “Qualification Certificate for Riboflavin Test” complies to VDMA - “Riboflavin test for low-germ or sterile process technologies, Fluorescence test for examination of cleanability for food, aseptic, pharmacy and chemistry” guideline
Test Equipment
- High intensity UV Lamp at wavelength 365 nm with calibration certificate
- Riboflavin (USP testing specification grade)
- High pressure sprayer
- UV protection safety glass
- Inspection Mirror
