Mike Venanzi No Comments

Nelson Laboratories acquires Gibraltar Laboratories, LLC

We are happy to announce that effective immediately, Gibraltar Laboratories has been acquired by Sotera Health, LLC; the world’s leading, fully integrated protector of global health.  Gibraltar Labs will become part of Sotera Health’s Nelson Labs business unit.

Gibraltar Labs has worked very hard to earn an outstanding reputation for providing superior customer service, technical expertise, and quality performance.  We know that Sotera Health holds the same values and also has a stellar reputation.  Sotera Health’s mission, Safeguarding Global HealthTM, aligns perfectly with the work we have performed for years.  By joining Nelson Labs, we become part of a world-class testing organization with a global presence and industry-leading thought leaders.

Nelson Laboratories, LLC is the leading provider of global lab testing and expert advisory services. Nelson Labs performs over 400 microbiological and analytical laboratory tests across the medical device, pharmaceutical and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.

Our expertise in pharmaceutical products, microbiology, and analytical testing will augment Nelson Labs existing strengths in medical device testing and expert advisory services as well as complement their Nelson Labs Europe’s expertise in extractables and leachables and materials characterization testing.  Our combined strengths will enhance the ability of our customers around the world to bring their products quickly and safely to market

Nelson Labs is committed to being a thought leader in the industry.  They strive to be at the forefront of new technologies, the most current thinking, and to provide the highest levels of quality, science, service, and expertise.  As we join with Nelson Labs in this commitment, we will continue to build on our long-standing reputation of excellence and continue to expand our offerings for you, our customers.

I will continue with Gibraltar Labs in the role of Chief Scientific Officer and Jozef Mastej will maintain his role as VP of Operations; we will both report directly to Jeff Nelson, President of Nelson Labs.  The team you know and trust will also stay intact.  At this time, Gibraltar Labs will continue to function as a standalone business unit of Nelson Labs; though we will continuously collaborate to ensure the sharing of best practices, and to capture the best possible synergies for our customers.

The acquisition of Gibraltar Labs does not include Prince Sterilization Services, LLC.  However, Gibraltar labs will maintain a partnership with Prince Sterilization Services to provide the testing needed to certify their products.

Nelson Labs’ business unit headquarters are located in Salt Lake City, UT, USA; however, our operations will stay in Fairfield, NJ, USA.  Your contacts at both companies will all remain the same as they are today.  We will continue to update you about new services and options as we integrate Gibraltar Labs and Nelson Labs services and systems. If you have questions, please do not hesitate to speak with our Customer Service team.

Sincerely,

Daniel Prince, Ph.D.

Chief Scientific Officer

Gibraltar Laboratories

Notification of Change

Nelson Labs Press Release

Danina Rinaldi No Comments

What Type of Soap Have You Been Using?

What Type of Soap Have You Been Using?

By Danina Rinaldi

Hand washing is a routine concept to us and a part of our daily routine.  It is also a crucial component to good hygiene and proper healthcare techniques.  When you go to the store and pick up soap, do you have a preference?  Do you choose a brand based on scent, color, container shape or size?  Or do you select a brand of soap based on antibacterial properties?

Earlier this month, on September 2, the Food and Drug Administration (FDA) established that antibacterial soaps, hand washes and antibacterial body washes containing one or more active ingredients from a list of 19 ingredients are no longer deemed Generally Recognized as Safe and Effective (GRAS/GRAE).  The full list can be reviewed below:

  1. Cloflucarban
  2. Fluorosalan
  3. Hexachlorophene
  4. Hexylresorcinol
  5. Iodophors (Iodine-containing ingredients)
  6. Iodine complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)
  7. Iodine complex (phosphate ester of alkylaryloxy polyethylene glycol)
  8. Nonylphenoxypoly (ethyleneoxy) ethanoliodine
  9. Poloxamer—iodine complex
  10. Povidone-iodine 5 to 10 percent
  11. Undecoylium chloride iodine complex
  12. Methylbenzethonium chloride
  13. Phenol
  14. Secondary amyltricresols
  15. Sodium oxychlorosene
  16. Tribromsalan
  17. Triclocarban
  18. Triclosan
  19. Triple dye

From this list, two of the most commonly found ingredients in antibacterial products are listed, Tricolcarban and Triclosan.  This ruling has been finalized after the FDA reviewed data that suggested long –term use and exposure from using such ingredients found in antibacterial products could pose risks to one’s health including bacterial resistance and/or hormonal effects.  If a manufacturer decides to continue the use of any of the ingredients, they will be required to provide data on the safety and effectiveness of their product as compared and demonstrated against the superiority to a non-antibacterial wash such as plain soap and water.  Plain soap and water has been proven to be more effective in preventing illness and reducing infection and is one of the most important steps one can take to avoid getting sick and stop the spread of germs.

Hand sanitizer is not effected by this ruling and is still recommended when plain soap and water is not available.  The best choice is one that is alcohol based with at least 60 percent alcohol, as recommended by the US Centers for Disease Control and Prevention.

Within one year, manufacturers are required to comply and remove any of the ingredients from the list above from their formula.

Take note of the soap you have in your bathrooms or kitchen and see what changes take place over the next few months.  What ingredients will be removed or replaced?  What will you replace your old soap with?  Will you be making a change or have you been using bar soap this whole time?

Mike Venanzi No Comments

Important Revision to ISO 14644

girbaltar-logo

Important revision to ISO 14644-1.

Please read the below and feel free to contact us to review your current cleanroom requirements.

The second edition ISO 14644-1:2015, cancels and replaces the first edition, ISO 14644-1:1999. It has been technically revised throughout. These changes are in response to user and expert feed-back validated by international inquiry.

The most significant change which will have the greatest impact to the sampling conducted at our Sponsor’s facilities is as follows.  A new and more consistent statistical approach is used for the selection and the number of sampling locations. In addition, evaluation of the data collected is covered.

With ISO 14644-1:1999 an underlying assumption was that the particle counts follow the same normal distribution across the room. This assumption has now been discarded to allow the sampling to be used in rooms where the particle counts vary in a more complex manner.

The minimum number of sampling locations required with ISO 14644-1:1999 has been changed.  The minimum number of sampling locations was previously determined by taking the square root of the measurement area (in square meters).  A reference table is now provided to define the minimum number of sampling locations required based on a practical adaptation of the sampling model technique.  This change results in a moderate increase in the number of sampling locations to be taken.

Using the minimum number of sampling locations provides at least 95% confidence that at least 90% of the cleanroom or clean area does not exceed the class limits.  The room is divided so that each selection within each section of a sampling location is considered to be representative of the characteristic of the section.  This change will result in an increased number of sample locations, changes to maps currently being used and changes to raw data and final reports.

It is important that you contact us at 973-227-6882 to review and make current your environmental monitoring program. We will be here to support you 100% as always!

gibraltar856 No Comments

ACIL Recognition for Outstanding Service

Gibraltar Laboratories is pleased to announce that, for the third consecutive year, it has been recognized by the American Council of Independent Laboratories (ACIL) for its outstanding service to its clients.

This year’s award, the 2012 ACIL Seal of Excellence, was announced on October 8, 2012 at the ACIL Annual Meeting in New York City. Please see the attached press release from ACIL. Gibraltar also received special recognition awards for overall customer satisfaction and timelines.

Gibraltar Laboratories is pleased to share these awards with its many clients, whose support and loyalty has allowed us to continually move forward in our efforts to provide outstanding science and quality service.

pressreleasedan1

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gibraltar856 No Comments

Case Study: Improved Pharmaceutical Quality Practices

CASE STUDY:

Rapid Deployment of Critical Services Proves Instrumental in Helping Secure MedPrep’s Approval to Resume Operations

 

THE CLIENT: MedPrep Consulting

MedPrep is a specialty intravenous (I.V.) pharmacy licensed by the State of New Jersey offering compounding services.

 

THE SITUATION:

MedPrep Consulting contracted Gibraltar Labs in late February of 2013 to help improve their quality standards, testing and compounding practices. The action was taken in advance of new and stricter regulations governing compounding pharmacies, forthcoming at both the Federal and State levels.

In Mid-March, as Gibraltar was assisting MedPrep, an incident occurred at Yale-New Haven Hospital. It involved the discovery of mold contamination in I.V. bags of magnesium sulfate that MedPrep had prepared and supplied to the hospital.

 

THE REACTION:

Upon learning that the contaminated bags were sourced from its facility, MedPrep promptly issued a recall of all its compounded preparations, ceased operations as directed by the NJ Board of Pharmacy, and requested Gibraltar Labs immediate support in managing the crisis.

 

THE GIBRALTAR LABS RESPONSE:

Gibraltar Labs rapidly mobilized a response team to begin environmental monitoring. After determining that no mold was present in the cleanroom complex, but finding mold in the warehouse area, Gibraltar was able to determine the likely source of the mold and the possible factors contributing to the contaminated I.V. bags. Shortly thereafter, Gibraltar issued a critical evaluation of the MedPrep facility and its quality procedures, which included comprehensive guidelines for improvements and best practices.

In support of MedPrep’s request to reopen, Gibraltar Labs also authored a position paper on their behalf for submission to the FDA and NJ Board of Pharmacy that documented the steps MedPrep had taken to ensure that it would operate in a safe, compliant manner in the future, and why company should be granted approval to resume operations.

 

THE RESULTS:

Thanks in part to the timely support and comprehensive services provided by Gibraltar Labs, the New Jersey State Board of Pharmacy officially notified MedPrep on May 2, 2013 that it could resume operations.

 

“We’re extremely satisfied with the service and responsiveness of Gibraltar Laboratories and look forward to continuing the relationship into the foreseeable future.”  

 

Gerry Tighe, President of Med Prep.