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 Includes
2 – Sample sets (tube, *Texwipe ® swab, single-use vial of sterile 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|
- Our SurfaceShield Surface Wipe Sampling and Cleaning Verification Kits provide you with all the items you need to check a surface for residue of chemicals including several USP <800> NIOSH APIs. Mitigate business risk by allowing Eagle to verify that the area sampled was cleaned appropriately.
- A list of hazardous drugs can be found in the NIOSH Hazardous Drug List.
- Eagle is a U.S. Food and Drug Administration (FDA) and Drug Enforcement Agency (DEA) registered A2LA ISO 17025 accredited laboratory founded in 2003 that provides analytical and microbiological testing, consultation services, and other technical services for pharmacies and other highly regulated industries including hospitals and pharmaceutical manufacturers to support their compliance needs.
- If you have an active not mentioned in FAQ #9, please contact Eagle Client Care to see how we can help.
- *Texwipe ® is a registered trademark of the Texwipe Company, LCC (Illinois Toll Works, Inc. (ITW)).
- Questions? Contact Client Care at l 800-745-8916 or email@example.com for further details.
Educational Resources, Related Topics, & Events
- 🔺USP PUBLISHED REVISIONS – WHAT CHANGED?
- HIGHLIGHTS from PCCA International Conference & EAGLE SEMINAR 2022! | Industry thought Leaders & influencers presenting topics on cleanroom requirements, environmental monitoring, proposed USP changes, insanitary conditions, & more. #ISTX22 (Hope to see you next year at #ISTX23 in Woodlands, TX! ( ISTX23- Update Page & Video)
- The Who, What, Where & Whys of the SurfaceShield Wipe Sampling and Cleaning Verification Kit (Product Information Page)
- Environmental Monitoring (Article)
- Proper Environmental Surface Sampling with Agar Plates (Video)
- Consulting Services & Compliance Solutions (Services)
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.
Your Future Awaits
Our talents vary — but we all have the same drive: to find better ways to improve the lives around us. If you are looking to become part of a company that is growing and innovative, Eagle may just be what you are looking for.