BACTERIA MOST OFTEN SUBMITTED FOR IDENTIFICATION TESTING DURING 2010

FREQUENTLY ENCOUNTERED BACTERIAL ENVIRONMENTAL ISOLATES
Microbiological consulting professionals  are often requested to assist Clients with the identification of various environmental microorganisms to include bacteria that are isolated from their various HVAC and Utility Systems during facility commissioning and on-going operations.  These requests relate to controlling these isolates within Alert and Action Levels and never permitting them to migrate  to Out of Trend (OOT) or Out of Specification (OOS) situations.
During environmental monitoring of ISO 5-8 controlled and classified areas, microorganisms are often isolated from airborne viable, settling, and contact plates and personnel.  Knowing the identification and sources of these bacteria becomes essential to maintaining the control of the environment and minimizing contamination of the non-sterile or sterile process and the aseptic filling of the product.  Personnel require this information to determine what sanitizer, disinfectant or sterilant to use.
Accugenix, Inc., Newark, DE has kindly provided the enclosed list of the fifteen most frequently obtained bacterial isolates during 2010.  These bacteria represent primarily skin microflora and environmental isolates.  One of the microorganisms isolated is also an anaerobe.  Please note that no yeast, molds or streptomyces are included within this list which is presented in Table 1 below along with their frequency.

Highlights from GBPR, Inc.’s May 2011 Events

Risk Based Approach to Cleaning Validation & FDA Compliant Aseptic Processing & Environmental Monitoring Event – New Brunswick New Jersey USA

Novatek International was proud to have sponsored yet another successful Global Biopharmaceutical Resources, Inc. (GBPR, Inc.) event last week in New Brunswick NJ. Such a successful event was due in part to an impressive attendance of high expertise attendees and a variety of knowledgeable presenters. Interactive discussions were openly shared throughout the three day event addressing a variety of appropriate topics that are in line with today’s current industry trends in improving an organization’s overall quality standard and cGMP compliance.

BEST METHOD TO DETERMINE THE IDENTIFICATION OF A MICROORGANISM

DIFFERENTIATION BETWEEN PHENOTYPIC AND GENOTYPIC IDENTIFICATION MECHANISMS

Recently, a Blog was published that identified the fifteen most common bacterial isolates identified by Accugenix, Inc, Newark, DE during 2010.  This Blog created an interest in other related areas to include the best methods to assure a definitive identification of an isolated bacterium.

In a poster presented at the most recent American Society for Microbiology, Accugenix compared multiple technology solutions to determine the fitness for use studies beyond routine panels provided by manufacturers to understand both the performance and operation impact vs. the various environmental monitoring systems.  The goal was to assure each customer the highest percentage of accurate identification to the species level.  The systems compared permitted identification by either phenotypic or genotypic methods.

Practical Microbiological Approach to Non-Sterile Manufacturing & Quality Control

From July 20 to 22, 2011, Conrad Chicago, USA Novatek International will be exhibiting its process-based Nova-EM Environmental Monitoring Management Software and other Nova-LIMS software solutions at the 2011 gbprinc.com, Practical Microbiological Approach to Non-Sterile Manufacturing & Quality Control in Chicago, Illinois, USA. Come visit us at Booth #1 for a live demonstration. Click the…

Challenges and Successes in Implementing an Electronic Environmental Monitoring Data Management Solution

From September 12 to 13, 2011, Basel, Switzerland It is with great pleasure that Susan Cleary, B.C.S, M.B.A., Associate Director of Product Development at Novatek International will be speaking at this year’s Europe GBPR, Inc. event on Challenges & Successes in Implementing an Electronic Environmental Monitoring Data Management Solution September 12 to 13, 2011 in…

610.12 CBER PROPOSED STERILITY TESTS

PART 610.12 — CBER GENERAL BIOLOGICAL PRODUCTS STANDARDS PROPOSED
 

Enclosed is the summary of the proposed requirements for the revised CBER 610.12 Sterility Test. For additional information, please see below for a summary or visit the enclosed web site for the full release http://www.gpo.gov/fdsys/pkg/FR-2011-06-21/pdf/2011-15346.pdf

The authority citation for 21 CFR part 610 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

Section 610.12 is revised to read as follows:

§ 610.12 Sterility.

(a) The test.

Except as provided in paragraph (h) of this section, manufacturers of biological products must perform sterility testing of each lot of each biological product’s final container material or other material, as appropriate and as approved in the biologics license application or supplement for that product.

(b) Test requirements.

(1) The sterility test must be appropriate to the material being tested such that the material does not interfere with or otherwise hinder the test.

(2) The sterility test must be validated to demonstrate that the test is capable of reliably and consistently detecting the presence of viable contaminating microorganisms.

(3) The sterility test and test components must be verified to demonstrate that the test method can consistently detect the presence of viable contaminating microorganisms.

MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS

CDER RELEASES A NEW PET DRAFT GUIDANCE

CDER has released as a DRAFT the following Guidance for Industry, “Media Fills for Validation of Aseptic Preparation for Positron Emission Tomography (PET) Drugs.  The Comment period will be 90 days.

Please visit: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM273766.pdf to obtain this DRAFT document.

PDA/FDA Joint Regulatory Conference – Booth 21

September 10-12 – Baltimore, MD Novatek International will be exhibiting its process-based LIMS software solutions such as Quality Management Systems, Stability Program Management, Environmental Monitoring & Utility Monitoring, Calibration & Preventive Maintenance, and, Automated Packaging Component Proof Reader at the 2012 PDA FDA Joint Regulatory Conference in Baltimore, MD USA. Come visit us at Booth…

Novatek’s NOVA-EM

The Environmental Monitoring Data Management & Trending System Software – The Industry Standard It seems like just yesterday, when the Pharmaceutical Microbiology Forum Newsletter – March 2004, Vol. 11 (1) was published. One of the hot topics at the time was Environmental Monitoring (EM) and the question of the day was: How many people are…