Saturday, May 8, 2010

Water System Biofil Testing by Aemtek

[Press Release] 2010.5.8

Aemtek offers in-depth training on water system biofilm
All pharmaceutical, biologics, and medical device facilities are likely to have high purity water systems. In spite of this overt absence of nutrients, microorganisms growing as biofilms can flourish within these systems and lead to undesirable contamination of facility processes and their products. In order to limit the bacteria that may be in the water, one has to understand and control the development of biofilms in the water system. Aemtek offers a two-day course that is designed to provide an in-depth look at how biofilm affects all aspects of water systems, including design, operation, validation, monitoring, sanitization, and excursion investigations. Right and wrong approaches will be discussed along with tips on how to minimize excursions as well as how to perform contamination investigations with example case studies to reinforce this learning.
The course will be taught by renowned industry expert, Dr. TERI C. (“T.C.”) SOLI. Dr. Soli has been consulting for 15 years with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, and validation. He is Vice-Chair of the USP Pharmaceutical Waters Expert Committee and has authored several ISPE and PDA book chapters, papers, and USP Monographs and Chapter revisions, including his complete rewrite of USP’s “water bible”, Chapter <1231>.
This comprehensive course is titled "EVERYTHING YOU NEED TO KNOW ABOUT WATER SYSTEM BIOFILM" and will be held on JUNE 16TH — 17TH, 2010 at AEMTEK TRAINING ROOM, 46309 WARM SPRINGS BLVD., FREMONT, CA 94539. For more information, visit http://www.aemtek.com/training or email training@aemtek.com.

About Aemtek
Aemtek, Inc. is an accredited microbiological testing and research laboratory providing services to multiple industries, including environmental, food, pharmaceutical and compounding pharmacies. We specialize in detection, identification and analysis of fungi and bacteria, using morphological, physiological, biochemical, and molecular methods. Aemtek has repeatedly demonstrated competence and integrity throughout all of our interactions with the regulatory agencies and our customers. Aemtek’s accurate, fast, and reliable laboratory services save you both time and money. Our commitment to scientific excellence, quality service, and advanced technology assures our clients that their projects are done right the first time, every time, on time. Contact information: AEMTEK, INC., 46309 Warm Springs Blvd., Fremont, CA 94539, Phone: 510-979-1979, Fax: 510-668-1980 Email: lab@aemtek.com, web: www.aemtek.com.

Tuesday, April 13, 2010

USP 797 Environmental Sampling, and Data Interpretation

Friday, 05/21/10

9:00am-4:00pm

USP <797>, Environmental Sampling, and Data Interpretation

EMLab P&K San Bruno

1150 Bayhill Drive, Suite #100

San Bruno, CA 94066

Note: Parking is complimentary

REG: US $199 (Early Registration: $99 if registered by May 7, 2010)

This seminar is highly recommended for anyone who needs to implement a USP <797> sampling program or has questions about the USP <797> analysis offered by EMLab P&K. The course instructor is Dr. Joseph Manfrida, EMLab P&K's lead USP <797> analyst. Dr. Manfrida will provide information regarding the background and purpose of USP <797> and will discuss designing and executing a USP <797> sampling regimen. For more information about the course, please contact EMLab P&K.

Contact: EMLab P&K

EMLab P&K
THE PROVEN LEADER
1150 Bayhill Drive, Suite 100
San Bruno, CA 94066
Tel 650.742.8142 | EFax 650.829.5852
www.emlabpk.com

Sunday, April 4, 2010

The Cleanroom Supply Connection

The Cleanroom Supply Connection (www.cleanroomsupplyconnection.com) is now listed on the vendor page of the usp797 website: www.usp797.org.

Aerobiology Laboratory Associates

Aerobiology Laboratory Associates (www.aerobiology.net) is now listed on the vendor page of the usp797 website: www.usp797.org.

USP 797 Consulting Firm Consults on New Pharmacies in New York

USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it recently completed a USP 797 consulting assignment on two new sterile compounding pharmacies in New York.

The two pharmacies, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, required consulting on whether their pharmacy plans and proposed pharmacy equipment, met current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA led the consulting assignment. The analysis revealed that there were a number of areas where improvements in the project could be made to meet USP 797 guidelines. Amongst the areas identified: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.

About USP797.org, Inc.:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

About USP797.org:

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

usp797.org. inc.
59 West 19th Street- 6A, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org

Saturday, March 20, 2010

New USP 797 Postings on Twitter

New USP 797 Twitter Account

USP797.org, Inc. is pleased to announce that a new Twitter account has been estbalished devoted exclusively to USP 797 news. Follow USP 797 on Twitter at www.twitter.com/usp797.

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org

Sunday, February 28, 2010

USP 797 Consulting Completes New USP 797 Consulting Assignment

For Immediate Release (02/28/10)

USP 797 Consulting Firm Selected to Provide USP797 Consulting on New Pharmacies in New York

USP797.org, Inc., the only consulting company in the United States focused exclusively on USP 797, is pleased to announce that it recently completed a USP 797 consulting assignment on two new sterile compounding pharmacies in New York.

The two pharmacies, which will be compounding sterile products in separate chemotherapy compounding and non-chemotherapy compounding rooms, required consulting on whether their pharmacy plans and proposed pharmacy equipment, met current USP 797 guidelines. Well known pharmacy design architect William N. Bernstein, AIA led the consulting assignment. The analysis revealed that there were a number of areas where improvements in the project could be made to meet USP 797 guidelines. Amongst the areas identified: selection of USP 797 compliant pharmacy equipment, revisions of HVAC pressurization relationships, and additional USP 797 planning suggestions regarding appropriate pharmacy dimensions, flow and materials.

About USP 797:

USP797.org, Inc. is the only pharmacy consulting company in the United States that is focused exclusively on USP 797 guidelines, USP 797 standards, and USP 797 compliance. The firm provides USP 797 consulting, as well as USP 797 information through its well known USP 797 website www.usp797.org.

Amongst the USP 797 topics addressed on www.usp797.org, are the following: usp 797, sterile compounding, compounding sterile, usp 797 guidelines, usp 797 standards, usp chapter 797, compounding sterile preparations, usp797, usp 797 pdf, usps 797, usp 797 summary, biosafety cabinet class, and usp 797 regulations.

For further information about USP 797, please go to the website www.usp797.org, or contact USP797.org, Inc. at:

USP797.org, Inc.
59 West 19th Street – 6a, New York, NY 10011
T: 212.463.0800
F: 212.463.9898
E: info@usp797.org
W: www.usp797.org