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USP 797 Testing Laboratory

USP <797>Testing                                                                  Contact Jay Rucker, 1-800-220-3675 Ext. 3422

Let EMSL Analytical, Inc provide microbiological testing services in support of your USP <797> activities.              

>> View USP Sample Report

The new USP guidelines are designed to prevent the improper handling and contamination of sterile compounds for certain drugs or biologic preparations. These items include:


1) Baths for live tissues and organs 4) Tissue implants
2) Opthalmics 5) Aqueous nasal and bronchial inhalations
3) Parenterals 6) Irrigating solutions


The guidelines impact not only the people who prepare the compounded sterile pharmaceuticals (CSPs) but also the areas where these drugs are prepared and stored including commercial and hospital pharmacies, clinics, doctor’s offices and other facilities. USP recommends certain clean area designs, storage specifications, Quality Assurance plans which include environmental monitoring, and employee training programs to accomplish the safe handling of these preparations.

These guidelines specifically address:

1) Microbial contamination USP Sterility Testing
2) Endotoxins USP Bacterial Endotoxins Test
3) Physical or Chemical Contamination
4) Preparation of incorrect Potency Confirmation
5) Incorrect Ingredients

A mistake in any of these 5 areas can cause serious injury or even death.

While a good portion of the USP guidelines deal with improving air quality in these facilities, an equally important goal is to prevent physical contact with and contamination of these preparations during manufacture. Products are manufactured according to risk levels: low, medium or high. Products that are to be injected carry the greatest risk of serious health effects; therefore these products must be manufactured in an area having the lowest risk level for contamination. The lowest risk level required under USP 797 for a critical area is an ISO Class 5 area designation.

The design of Class 5 clean areas for preparation and Class 7 buffer areas, surrounding Class 5 areas, is a requirement. Semi-annual testing for viable bacteria and fungi in air, gloved fingertip, surface contact plates, and non-viable particulates is required for both Class 5 and Class 7 designated areas. These monitoring results trended over time will provide information on any deterioration in air quality and aseptic technique. Generally, this monitoring should be conducted semi-annually. Lab analysis should be conducted by an FDA registered, cGMP compliant laboratory only.

The action levels for microbial and particulate monitoring results are summarized below:


SEMI-ANNUAL MICROBIAL AND PARTICULATE MONITORING

ISO Clean
Room
Classification

US Clean Room
Classification
(0.5 u/ft3)

Particulate
Sampling
> 0.5 u/m3

Air Sampling
400-1000 L*
CFU/m3

Gloved Fingertip
Sampling Total
CFU/Plate

Swab/Surface Contact
Plate Sampling
CFU/Plate

Endotoxin (frequency depends
on CSP batch #s/storage
conditions)

Class 5

100

3520

>1

>3

>3

See USP monographs

Class 7

1,000

352,000

>10

NA

>5

See USP monographs

Class 8

10,000

3,520,000

>100

NA

>100

See USP monographs

*Based on a flow rate of 100 lpm and a sample volume between 400 to 1000 liters.

One important item should be noted. Regardless of the number of CFUs recovered, corrective actions are required if any pathogenic organisms or molds are identified. Therefore when any colonies are seen on the plates, those colonies must be identified by phenotypic or genotypic methods level to determine the presence of pathogens.

For pricing and information, contact EMSL at 1-800-220-3675 (East Coast), 1-866-798-1089 (West Coast) or info@EMSL.com.

 

FREE USP Poster for Pharmaceutical and Environmental Professionals

Download 8.5 X 11 PDF

Full list of services provided for USP 797 ( click for details )
Laboratories providing USP 797 ( click for details )