21 CFR 1271 for Human Cell, Tissue, and Cellular and Tissue-Based Products (HCT/P)

The storage and handling of cell tissues and cultures must be done in a controlled environment to ensure that any risk of product contamination and cross contamination is reduced. The Food and Drug Administration have release a guide to the management of these facilities. Particle Measuring Systems is the leader in the environmental control and monitoring of sterile facilities. Below is a new white paper on how to show compliance with 21 CFR 1271 and products that are proven solutions to these requirements.

For specific questions please contact Mark Hallworth at mhallworth@pmeasuring.com or 303.443.7100.

Documentos

Produtos

N O U V E A U		Airborne Particle Counters: LASAIR II 350L and 550L Flow rate of 50 LPM to sample one cubic meter in only 20 minutes. The software walks you through the certification process, collects the data, then prints a full final report.
		Airborne Particle Counters: LASAIR II 310A/310B/510A This airborne particle counter provides complete features in a compact, convenient package. Offers great portability, ease of use, and a chemically-resistant, easy to clean cover.
N O U V E A U		Handheld Particle Counter: Handilaz Mini ONLY $1950*. BUY NOW Online or Call 1-877-475-3317. Ships within 5 business days.

Serviços

• Options de location / crédit-bail de compteur de particules
• Pharmaceutical Microcontamination Monitoring Services