An Industry First
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 the area sampled was cleaned appropriately.
Free shipping with a return label included in the box makes getting your samples tested and results received a quick process. Simply place sample(s) in box as instructed and give box to your local FedEx courier.
Custom QR Code
The included instruction card contains an QR Code that provides additional useful information to the tester.
Each sampling kit includes a sample instruction card, as well as a follow-along video that will help ensure the greatest accuracy with your swabbing technique.
2. What solvent should be used when sampling?
We recommend Deionized or Distilled Water.
3. How do I return the sample?
Swabs should be placed into the provided collection tubes and plastic bag. Each container must be properly labeled with the collection location. Place the plastic bag into the box (where original shipping may be reused). Insert cold icepacks into the box and send them back to Eagle for processing.
4. How often should I be testing?
USP <800> states: “Environmental wipe sampling for HD surface residue should be performed routinely (e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment).”
5. How does return shipping work?
Eagle includes a 2-day return label with your order so that you may send your samples in the easiest way possible, in the box they came in with a preprinted FedEx label. Only one FedEx label is provided, if all samples are not submitted back to Eagle in the same package, the additional shipments are the customers’ responsibility to ship.
6. What area(s) should I be swabbing?
USP <800> states: “Surface wipe sampling should include Interior of the C-PEC and equipment contained in it, pass-through chambers, surfaces in staging or work areas near the C-PEC, areas adjacent to C-PECs, areas immediately outside the HD buffer room or the C-SCA, and patient administration areas.
7. How large of an area should I be swabbing per location?
10 cm x 10 cm (4″ x 4″)
8. Where do I submit these samples for analysis?
EagleTrax, a step-by-step how-to guide will be emailed to you with every order confirmation.
9. What analytes should we be testing?
Eagle has the capabilities to test the following analytes:
|Ethinyl Estradiol||Testosterone Cypionate|
10. What if I do not see an analyte that I would like to test?
Call for more details; the option of developing a method is possible.
11. How many analytes per swab can be tested?
We recommend one active per swab to ensure the highest accuracy.
12. What is the pricing of analysis?
$225 for the first HD; $225 for each additional. If submitting multiple locations with the same active, the first swab is $225 and each additional swab is $50.
13. What do these results mean?
A positive result would indicate your cleaning process is insufficient, whether that indicates ineffective dwell time, cleaning SOP, cleaning agent or other cause.
14. What is the turnaround time?
Our standard turnaround is 5 business days but samples that are upgraded to rush may be ready in as little as 3 days.
Surface Wipe Sampling Kit
During compounding activities, it is not always easy to contain powders, liquids and other forms of active pharmaceutical ingredients from spreading across work surfaces. Many compounders assume that their current cleaning SOP completely cleans work surfaces of all residues from their API but this may not be true. For 2018 and 2019, failure to sufficiently clean or sanitize was listed in the top 5 items cited on 483s while not properly following SOP was ranked #1. So even if your SOPs are good, an employee failing to follow them could result in contamination which could led to a 483 and if not corrected a warning letter. Do not put the health of your customers and business in danger. Eagle HD Swab Sample Kit can help mitigate your risk by allowing Eagle to verify that the sampled compounding area was cleaned appropriately.
- USP <800> specifies that environmental wipe sampling should be done routinely in the following places: interior of hoods, pass-through chambers, surfaces in or around work/staging areas, areas immediately outside the HD handling areas, and patient administration areas. Surface swab area sampling evaluates your deactivating, decontaminating, disinfecting and cleaning protocols.
- Eagle is an FDA and DEA registered, A2LA ISO 17025 accredited laboratory providing analytical and microbiological testing services along with expert consulting services to 503A compounding pharmacies, 503B outsourcing facilities, and pharmaceutical companies.
- If you have an analyte not mentioned in FAQ #9, please contact Eagle to see how we can help.