Customers may purchase environmental monitoring supplies as part of the test service from Nelson Labs for validation and ongoing process monitoring of manufacturing facilities and clean environments.
Commercially Prepared Media (Plates)
Nelson Labs recommends a variety of air fall-out plates, convex plates for surface and personnel monitoring. It is recommended that manufacturers purchase directly from commercial media suppliers to ensure minimal shipping and handling.
- Hardy Diagnostics – www.hardydiagnostics.com
- Becton Dickinson – www.bd.com
- Fisher Scientific (distributor) – www.thermofisher.com
- VWR (distributor) – www.vwr.com
Always request a certificate of analysis (CofA) from commercially prepared media providers. For confirmation testing on commercially prepared media, Nelson Labs provides growth promotion testing services following USP and EP guidelines.
Water Sampling Bottles
For sampling water, we recommend start, mid, and end run sampling for routine process monitoring to assess water over time in a controlled environment or manufacturing process. Most facilities establish initial limits with a water system validation; then through observed data and seasonality monitoring, they are able to scale back their sampling plans for ongoing system monitoring based on trend analysis and risk assessments. We offer multiple bottle types depending on the test required: conductivity and TOC bottles, water bottles with and without thiosulfate, as well as endotoxin sampling tubes.
It is important to use the appropriate bottle in order to best manage the integrity of the water test sample. For example, the amber bottles used for conductivity and TOC (one bottle for both tests) limit light contact with the sample; polystyrene tubes for endotoxin are endotoxin-free, thus minimizing background contamination from the container; thiosulfate is used to inhibit the action of treated water from common chemicals such as chlorine.
Order environmental monitoring supplies (need new form):
- PDA TR13
- USP 1116
- Current Good Manufacturing Practice (cGMP)
For environmental monitoring tests, please see the following:
For growth promotion studies, a standard broad spectrum screen following guidance in EP/USP chapters is used. Standard pricing includes five organisms: Staphylococcus aureus (Gram-positive cocci), Pseudomonas aeruginosa (Gram-negative rod), Bacillus subtilis (spore former), Candida albicans (yeast), and Aspergillus brasiliensis (mold). Testing generally includes two samples per organism plus pH check and negative controls. Additional organisms or panels are charged separately.
If you have additional questions about Environmental Monitoring Supplies for Air or Water testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.