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Compact IV Inspection Light Box (17108)
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- Used to determine the absence of particulates in compounded sterile drug products.
- Provides a means for pharmacists to comply with USP 27, Section <797> Pharmaceutical Compounding - Sterile Preparations.
- Allows user to perform finished preparation release checks for purity and quality.
- Physical inspection of the compounded sterile product (CSP) is achieved against lighted White and Black backgrounds for evidence of visible particulates of foreign matter.
- Check for precipitates, flocculation, undissolved substances, solvent impurities, and carmelization.
- Inspect for particulate from packaging components, environmental contaminants, processing and people.
- Visualize floaters, rubber coring, and other particulate matter such as glass, lint, fiber, hair, and skin.
- Monitor other aspects of the preparation such as color, visual signs of microbial growth and/or leaching of plasticizers.
- Assists in meeting ASHP Guidelines for Quality Assurance for Pharmacy-Prepared Sterile Products and Minimum Standards for Home Care Pharmacies.
- Compact size is ideal for areas with limited wall mount space or where preferred use is on a countertop or workstation.
- 4" (102mm) diameter, 4X magnifying glass allows for close visual inspection. Quiet flexible arm permits easy movement.
- Consists of one Black UV and one White fluorescent light. Lights include 15W bulbs and a 5 feet cord.
- One 110V wall outlet is needed for operation. Both lights are individually operated by turning on easy to access switches.
- Pre-drilled mounting holes
- Outside Dimensions: 16-1/2"W x 16-1/2"H x 5-1/2"D (419mm x 419mm x 140mm)
Product inspection should begin immediately after preparation or just before it leaves the pharmacy. Ideally the container should be free of labels or attachments during the inspection process and the inspector should wear talc-free gloves.
Two lights are mounted in the box. A White fluorescent light is mounted at the top of the box. A Black UV light is mounted at the bottom. Utilizing each light independently, the inspector should grip the container by its top and slowly swirl the contents (avoiding vigorous swirling) in a circular motion. Any air bubbles created should rise to the top of the container.
The inspector should hold the container about four inches above or below the light source (depending on which is being utilized at the time). In a motion from left to right, the container should be passed in front of the Black background first and then the White background and back again. The container should then be inverted and passed again before both backgrounds. A magnifying glass is attached to the box and could be utilized during this procedure for closer visual inspection.
Particulate matter usually remains at an even level or drops to the bottom of the container. The Black UV light aids in the visualization of glass or crystalline particulate and some types of bacterial. The White fluorescent light aids in visualizing solid particulate such as rubber cores, lint, chemical precipitate, hair, dust, or other particles.
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