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SurfaceShield Wipe Sampling and Cleaning Verification Kit
Committed To Quality
SurfaceShield is a wipe sampling kit for the detection of drugs on surfaces at manufacturing facilities, pharmacies, hospitals, and other healthcare institutions.
Sampling with SurfaceShield is a fast, easy, and convenient method for verifying the efficacy of your cleaning program, which may include decontamination of hazardous drugs on surfaces.
Samples are analyzed at Eagle, an A2LA ISO 17025 accredited laboratory, utilizing highly specific and validated methods for both hazardous and non-hazardous drugs. You can count on Eagle to provide results that are quick, reliable, and accurate.
Our environmental surface wipe sampling kits provide you with all the items you need in order to check a surface for residue of chemicals including several USP <800> NIOSH APIs. Mitigate business risk by allowing Eagle to verify that sampled areas were appropriately cleaned.
Everything You Need
SurfaceShield Wipe Sampling Kit Contents
2 – Sample sets (tube, swab, water, gloves in reclosable plastic bag)
2 – 10 x 10 cm (100 cm²) templates
3 oz single-use cold pack
Sampling Instructions insert
Step-By-Step Video Instructions
The included printed instruction card contains a QR code that provides step-by-step video instructions. Simply scan the QR code with a mobile device to view this helpful video tutorial.
Who Should Test?
All organizations that handle hazardous drugs including pharmacies, hospitals, manufacturers, patient treatment clinics, and other healthcare institutions should test for surface contamination. Additionally, all FDA-regulated manufacturers governed by Current Good Manufacturing Practices (CGMP) must verify and validate the efficacy of their cleaning programs to minimize the risk of cross-contamination.
Why Should You Test?
USP <800> was developed to promote patient and employee safety from exposure to hazardous drugs in the healthcare setting across multiple activities including but not limited to, receipt, dispensing, compounding/manufacturing, administration, and disposal.
Title 21 Part 211 of the Code of Federal Regulations (CFR) requires that manufacturers validate their cleaning procedures to ensure that product residues are adequately removed from surfaces to prevent cross-contamination between production campaigns.
Identifying areas with high levels of surface contamination can provide valuable information to mitigate employee and patient risk, improve facility engineering controls, and implement revisions to your current work practices.
What and Where To Test?
All surfaces that are at risk for surface contamination shall be tested. A risk assessment shall be performed to determine the areas and drugs to be tested.
Typical sampling areas with respect to the activities performed include:
Hazardous drug containers
Receiving and storage area floors, shelves, or walls
Hazardous drug vials or containers
Interior of the BSC/LAFW/powder containment hood
Areas adjacent to the BSC/LAFW/powder containment hood (floors, walls, etc.)
Areas adjacent to the HD room
Mixing area (work surface, floors, walls)
High-touch areas (doorknob, door handle, pen, keyboard/mouse)
Floors and walls
When Should You Test?
Wipe sampling shall be performed initially to establish a baseline of surface contamination, then no less than every six months to verify containment.
Additionally, wipe sampling for the purpose of validating a cleaning procedure shall be performed in triplicate after cleaning has been performed for each drug or each class of drugs, and for drugs of which exposure or cross-contamination is detrimental to employee and patient health. SurfaceShield should be utilized as a tool for the recovery, detection, and/or quantitation of drugs on work and equipment surfaces. For more information regarding cleaning validation and the additional requirements to comply with the Code of Federal Regulations (CFR), schedule an initial consultation with one of our Eagle Consultants.
Available Drug Testing
API not mentioned? Contact Client Care.
|Fluconazole||More To Come|
Ready to get started? Need Assistance?
Call the Eagle Client Care Team at 800.745.8916 to request an initial consultation and discuss your operation’s specific needs.
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