Little in life can be as arduous as wading through a chapter from the USP. The minimum practice and quality standards laid out in USP may never be a New York Times bestselling book, but many do look for a better way to understand the cumbersome language of regulatory texts. Here is a basic outline…
ISO 14644 Updates Announced
The revised ISO 14644-1 and -2 cornerstone cleanroom standards have been approved as International Standards, after being reviewed and voted upon by ISO member bodies. ISO 14644 Standards first came about as they were formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. Soon it became clear that,…
Keep in Touch! Love, the FDA
I attended the PDA/FDA Joint Regulatory Conference in Washington, D.C. earlier this week. Experts spoke on a number of topics related to pharmaceutical regulations, quality control, USP standards, and more. Far and away, the most common theme in all of these sessions was that users should not be afraid to contact the FDA with questions…
The Evolution of ESD Control
Electrostatic charge generation control is required in all cleanroom operations as it can reduce product yield, disrupt automatic equipment from electromagnetic interference (EMI), and reduce surface particle collection by electrostatic attraction (ESA) which is unwanted viable and non-viable particles that may contaminate cleanroom surfaces and product. Semiconductor, microelectronics, aerospace, automotive, and optics cleanrooms are more concerned with the unwanted non-viable particle migration; whereas pharmaceutical, medical device, biopharm, and…
Lowering Operating Costs through Energy Savings
A facilities engineer should focus on energy consumption, and typically the biggest targets are your HVAC and lighting systems. However, don’t forget the opportunities to put a stake in the heart of “vampire power” (also known as standby power) where thousands of electronic and electrical devices are designed to continue consuming electricity when switched off…
IEST Announces Fall Conference Registration
IEST, ANSI-credentialed and the world’s leading Contamination Control standards development organization, has opened registration for its Fall Conference. Contamination Control and Nanotechnology Facility professionals from around the world will convene at the Crown Plaza Chicago-O’Hare on November 9 – 12. Roberta Burrows, IEST’s Executive Direct, explains, “Our meetings are unique because of their depth. You can’t…
New Ground Rules for Nanotech Research
In two new studies, researchers from across the country spearheaded by Duke University faculty have begun to design the framework on which to build the emerging field of nanoinformatics. Nanoinformatics is, as the name implies, the combination of nanoscale research and informatics. It attempts to determine which information is relevant to the field and then…
Cleanroom Training
We built an ISO Class 7 cleanroom to serve our customers in the aerospace industry. We’ve hired engineers and operators to work in the cleanroom. Where can we resource training for our cleanroom personnel? There are several independent cleanroom and contamination control consultants and trade industry conferences that you may contact to provide the required training. However, the cleanroom and controlled environment industries rely on…
Personalized Medicine, Companion Diagnostics, and NGS Diagnostic Tests
The field of personalized medicine has been evolving ever since the Human Genome Project1 was completed in 2003. During that program researchers identified specific genes linked to particular disease states such as the MSH2 gene with colon cancer, and variations in the FAD gene linked to Alzheimer’s disease. Personalized medicine looks to exploit this information by tailoring drug therapies to a patient’s gene mutation.…
The Wiper Guide
Q: Auditors have requested test data to confirm that wipers used by a cleanroom consumables distributor are non-linting. Is this a requirement of USP 797? A: Yes. The 2008 revision bulletin of The United States Pharmacopeial (USP) Convention states: “All cleaning materials, such as wipers, sponges, and mops shall be nonshedding, preferably composed of synthetic micro fibers, and dedicated to use in the…
IEST Standards Update – ESTECH 2015
The IEST holds two conferences each year. ESTECH, the annual technical meeting of the Institute of Environmental Sciences and Technology (IEST), was held April 27-30 in Danvers, Mass. The IEST Fall Conference will be held Nov. 9-12 at the Crowne Plaza O’Hare. The cleanroom and controlled environment industries rely on two main sources for standards and best practices in cleanroom and contamination control management:…
Decoding the USP <797> Testing Requirements
Little in life can be as arduous as wading through a chapter from the USP. The minimum practice and quality standards laid out in USP may never be a New York Times bestselling book, but many do look for a better way to understand the cumbersome language of regulatory texts. Aseptic manipulation Maintenance of any controlled environment starts with personnel…
USP 797 Update
The USP (United States Pharmacopeia) was founded in 1820. It is a scientific, nonprofit organization that sets standards for the identity, quality, purity, and strength of medicines, food ingredients, and dietary supplements. The organization’s mission is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of…
Implications of the FDA’s Program Alignment Plan
In late 2013, the U.S. Food and Drug Administration (FDA) announced it was embarking upon a program to realign its structure and programs to keep up with the challenges posed by advances in science, globalization, and product complexity. By February 2014, FDA Commissioner Margaret Hamburg, M.D., had unveiled the sweeping changes to the agency that…
Recommended Practices in Isolator/Glovebox Cleaning
An isolator/glovebox is a miniature version of a cleanroom and is often certified to ISO cleanroom classifications. Therefore, the cleaning methods for cleanroom environments as described in IEST-RP-CC018.4, Cleanroom Housekeeping: Operating and Monitoring Procedures andInternational Standard ISO 14644-5, Cleanrooms and associated controlled environments – Part 5: Operations may be used to clean an isolator/glovebox. During…
Preparing for the Drug Quality Security Act
In November 2013 the President of the United States signed a bill called H.R. 3204 into law. This was the culmination of a decade of state and regulatory agency negotiations to tackle the disparity in interstate drug traceability. Going forward, the responsibility falls under the purview of the federal government. At the base, this guidance…
USP Highlights Expertise Offered to Federal Agencies in 2014
The U.S. Pharmacopeial Convention (USP) submitted a series of public comments in 2014 in response to proposed regulations and policy initiatives by Federal agencies with an emphasis on appropriate appreciation and awareness of public standards. USP sets legally-recognized quality standards that help define the identity and purity of medicines, food ingredients and dietary supplements sold…
Promoting Preparedness and Standards in the Wake of Infectious Disease
The Healthcare Coalition for Emergency Preparedness (HCEP) was formed in an effort to raise awareness and educate people about often overlooked issues in plans to maintain healthcare facility operations during a crisis and develop efficient methods to reduce healthcare costs. As such, the HCEP has repeatedly requested the Centers for Disease Control and Prevention (CDC)…
Breaking Down the Complex OSHA Requirements for Cleanrooms
Cleanroom safety across various types of industries and settings can be a complicated matter. The common thread between all is that they must comply with applicable U.S. Department of Labor (DOL) Occupational Safety and Health Administration (OSHA) regulations. A facility manager’s task is to decide which requirements apply to his or her operation, and what…
ISPE Announces Facility of the Year Winner
The International Society for Pharmaceutical Engineers (ISPE) announces Pfizer Ireland Pharmaceuticals as the 2014 Facility of the Year Awards (FOYA) Overall Winner at the society’s annual meeting in Las Vegas, Nev. Pfizer Ireland’s Network Strategy Implementation (NSI) Expansion Capacity project challenged the company to add capacity by re-purposing an existing manufacturing space for a new…
Sun Pharma unit recalls cephalexin capsules from US
Caraco Pharmaceutical Laboratories, the US-based unit of Sun Pharmaceuticals, has initiated a recall of multiple lots of cephalexin capsules from the US market, according to a PTI report. Citing a notification by the USFDA, the report says that the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is…
ISO Publishes Water Footprint Standard
Water is one of the world’s most precious – and lucrative – resources, and now preserving our “blue gold” just got easier thanks to a new ISO International Standard. ISO 14046, Environmental management – Water footprint – Principles, requirements and guidelines, will allow all kinds of organizations, from industry to government and NGOs, the means…
CDER’s Drug Shortages Program
Between the years 2005 and 2011 the number of new drug shortages quadrupled to 251, posing a significant risk to public health. President Barack Obama issued a directive to the FDA in 2011 to develop a plan to address the problem. In 2011 the U.S. Government Accountability Office provided testimony to the Committee on Health,…
OSHA Proposes $449K Fine for Chemical Company
A federal safety agency has proposed fining a Wisconsin company more than $449,000 for allegedly failing to adequately protect workers from hazardous chemicals. The U.S. Occupational Safety and Health Administration cited Fontarome Chemical Inc. of St. Francis for 23 alleged safety and health violations. OSHA initiated an inspection in December 2013 after the company allegedly…
Microbial Monitoring Programs for Non-Sterile Operations
I have been tasked with establishing and implementing a microbial monitoring program for our new non-sterile ISO Class 6 cleanroom that packages medical devices for terminal sterilization by gamma radiation. What resources are available to assist me? Microorganisms (bacteria, molds, and yeasts) found in cleanrooms in the air and on surfaces are viable particles that…