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Contract Laboratory Services > Pharmaceutical Analysis >> Bio-Burden Analysis

Bio-Burden Analysis


Monitoring the quality of ambient air and objects, in sensitive environments, for the presence of microorganisms is required to prevent serious production non-conformances and health-hazards.  Sterile manufacturing further necessitates the requirement for continuous monitoring of Bio-Burden. 

Bio-Burden sampling can be carried out by two methods:  

Hi Air sampling. Working on impaction principle, the Hi Air Sampler, samples 280 litres of air every minute, collecting microbes from ambient air on an agar strip. Most coliform bacteria, yeasts, and moulds can be analyzed using different types of agar strips.

 

Settling Plate. This is a more traditional approach to determining aseptic conditions. Using various media plates, the presence and type of microbe can be ascertained.

In addition to this, swabs and rinse waters are also used to check for bio-load.

PARAMETERS:

Bio-Burden Load, Environment Isolates

INDUSTRY APPLICATIONS:

Pharmaceutical Manufacturing, especially sterile areas

Other industry segments: Healthcare & Hospitality Industry.

INSTRUMENTS:

Hi-Air Sampler, US FDA Class 100 Laminar Flows, Bio-safety Cabinets, Digital zone readers, Microscopes with calibrated internal micrometers, Colony Counters, Auto-Bacterial Identification Systems.  

SPECIFICATIONS:

USP, BP, IP, EP, JP, CP, Client Specifications  

  To request for more information on Bio-Burden Studies, contact us at info@choksilab.com .

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