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Chemistry and Facilities Awards

Chemistry and Facilities Awards:

By Kate Slezak

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Gibraltar Laboratories, Inc. is proud to announce two honors: [1] FINALIST for the “Excellence in Facility Design or Retrofit Award” by the 2016 BioProcess International Awards as the company is recognized for designing and re-purposing pre-existing buildings to incorporate the equipment and resources that allow it to offer certifications, terminal sterilization, and ready-to-use sterile vials and [2] Gibraltar Laboratories was also recognized both for “Best for Analytical Chemistry Services in New Jersey” and “Best Laboratory Sterilization Product” for the Gibraltar SteriKit® at the 2016 Pharmaceutical Packaging and Manufacturing Awards. The Gibraltar SteriKit® is designed to help accelerate companies manufacturing processes by saving time, space and money. The ready-to-use kit comes with sterile vials, available in either clear or amber, sterile seals, and sterile stoppers of the client’s desired vial size and seal color. This provides aseptic manufacturers with unique, customizable packaging options in a timely manner that can support them in bringing new drugs and vaccines to market that comply with FDA and USP regulations. Gibraltar Laboratories is proud to be honoured with these prestigious awards and looks forward to its continued support of aseptic manufactures with its platform of laboratory and sterilization services and the SteriKit®.

Dr. Daniel Prince, President of Gibraltar Laboratories, Inc. commented, “It is a great honor to be recognized by our customers, by Global Health & Pharma (GPH) , and by BioProcess International for the design and operation of our facility. We thank you all very much!”

To see the full press release for Gibraltar Laboratories position as finalist for the “Excellence in Facility Design or Retrofit Award” from BioProcess International, please click: http://bit.ly/2eT6lgM

To find out more information about the 2016 Pharmaceutical Packaging and Manufacturing Awards, please click: http://bit.ly/2eT4MiX

 

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Here’s Why We’re Socially Relevant and Not Just Scientifically

Some organizations get so caught up in the rush of scientific research and attempts at discovery that they forget exactly what it is they are. They’re a company, an entity that creates opportunities for other organizations. We have to be part of the community as well as part of the scientific industry; we need to be socially relevant as well as scientifically relevant, and we are. How do we do it? Well, we do it in a number of ways.

Have you heard about our Gibraltar Institute for Research and Testing? Through this part of our organization, we’re able to get out there and truly be the leaders we were meant to be. Our Institute travels the country to present at some of the most scientifically complex and prestigious conferences known throughout the industry. One of recent note would be the Orthopedic Manufacturing and Technology Exposition in Chicago, Illinois, where our own Jozef Mastej gave a smashing presentation on medical device and sterilization validation.

This is just one way we stay relevant—by communicating with other organizations and by sharing our experiences with them, we’re able to come up with some of the most modern solutions possible. We want to help our clientele and other organizations achieve the best outcomes to further the well-being of the human race.

We’re also pretty socially active. One way that we keep this going is by playing in our local softball team chapter. Our team gets together and gives it their all on the field in order to not only get our name out there, but to also show the community that we’re human. We might not have the best record (that’s putting it lightly) but we’re still having a good time and having fun with each other out of the workplace. We’re trying to build more than a corporation, we’re trying to build a family.

Our CEO, Daniel Prince, regularly writes his own personal blogs through LinkedIn and other outlets as well. In one of his recent blogs, he talks about the deeper meaning of perspective and choice in a world where the impact of our decisions means more than we realize. Through regularly blogging, Dr. Prince isn’t always in the laboratory, he spends time improving his own mind in order to better serve his organization.

We’re also hiring! If you’re interested in working for our groundbreaking contract research organization, contact us immediately. We’re innovators in steam sterilization as well as cleaning and steam sterilization validation services. We offer a competitive and highly educational environment where everyone from the ground up is learning and working to accomplish greater achievements. Are you interested in being part of the team? Give us a call immediately at 877.315.5847 and say you heard about the opportunity on our blog. We look forward to hearing from you!

Daniel No Comments

Career Opportunities Now From Gibraltar Labs!

In an economy where, every day, companies are closing their doors, or are unable to expand and create new jobs, Gibraltar Labs proves strong and capable. We’re constantly expanding and pursuing bigger and more advanced endeavors including groundbreaking innovations in rapid sterility testing. That’s why we’re excited to be expanding our ranks! Currently, we’re looking for exceptional individuals that are trying to join an incredible, top-notch team of scientists and business professionals all working towards the same goals. We’re looking for individuals that are team players, people that are open to new challenges and constantly growing with the ever-advancing world of scientific research and pharmaceutical development.

Senior Manager – Manager of People and Business Development

This position for Manager of People and Business Development is an exceptional opportunity as part of Gibraltar Labs’ leading senior management team. This team member reports directly to the President, and must be well-qualified in sales, marketing and business development strategies and techniques. The Manager of People and Business Development will be responsible for maintaining positive relationships with clientele that will result in future business from them and their network of connections. Some other responsibilities include:

–          Execution of complex client account plans.

–          Close collaboration with leadership to execute product management, marketing strategies, sales plans and client strategies.

–          Maintenance of strong customer service relations with both new and current clientele.

Other responsibilities include acting as a client liaison, or “Voice of the Customer” as we call it. This team member will need to monitor customer satisfaction and deliver finished products that are both useful and beautifully designed. Individuals in this position are also expected to provide insightful industry knowledge and innovative market knowledge in order to deliver a superior product to our clientele.

Junior Chemist –

This Junior Chemist will report directly to the Chemistry Manager in the Wet Chemistry division of our laboratory facilities. As they perform the tests required of their position they must adhere to any and all Good Manufacturing Practices outlined by both Gibraltar Labs and the Food & Drug Administration. Junior chemists will perform tests on pharmaceuticals and medical devices based on the needs of the client. They will be responsible for tracking, cataloging and documenting all reagents, equipment and supplies with all documentation and labeling necessary. All documentation regarding experiments and any other testing will be done according to Good Manufacturing Practices, with training included.

Specialist in Accounts Payable –

This is a 6-month temporary position with benefits available upon eligibility. Proficiency in Microsoft Office and other account software is a must. This specialist must act in a timely manner and be well-organized with the ability to multi-task in a fast-paced environment. Specialists in Accounts Payable must also be well-versed with compliance and regulations related to finance and security.

Data Entry Coordinator/Individual Contributor –

Data Entry Coordinators at Gibraltar Laboratories are a vital part of the team, closely monitoring the receiving department for new test samples. They then assist with the sample processing procedure by opening, entering, tracking, labeling and finally directing samples to the appropriate departments. Attention to detail and accuracy of work will be integral to success in this position.  Data Entry Coordinators will also learn all necessary Standard Operating Procedures and best practices related to laboratory and sample safety.

We’re very excited to be growing, and to have the capacity to invite new team members onto our award-winning team! If you’re interested in learning more about our career opportunities please contact us today toll-free at 877.315.5847 or visit https://www.gibraltarlabsinc.com/careers-at-gibraltar.html

Daniel No Comments

Outside the Laboratories – Gibraltar Labs Softball!

At Gibraltar Laboratories, Incorporated, our team likes to “pitch-in” more than you’d think!

It’s easy to lose sight of who you are and what you stand for when you spend as much time as we do in the laboratory. It’s important that we live our lives and never let the laboratory consume us, because science is objective and at times, cold and unforgiving. That’s why we remain active in our communities and families—these bonds help enhance our skills as scientists and researchers and help us to bring our valued clientele better services with cooler heads. Check out our recent achievements playing Adult Softball in Fairfield Township, New Jersey!

Our team met in full force and commanded the field with more skill than you’d expect from us out of our lab coats. Our colors are red and white, and we’re proud to take to the fields to forget about life for a while and get our heads in the game!  We’ve played three times, and maybe we haven’t won all the time, but we’re still having a blast. Our last game, on June 11, was very close, ending at a nail-biting 10-13.

Fairfield, New Jersey, is a culturally rich area with a vibrant history and beautiful landscaping all around us. We’re comfortably nestled between interstate routes 80 and 46. The roughly 10.5 square mile township houses about 7,000 people and is a part of Essex County, New Jersey.  As we provide contract research services for the many surrounding businesses in need of scientific professionals, we also have access to this brilliant community and excellent area, and we won’t let that go to waste. We value earning respect in the community through contribution and integrity. We will deliver this in the future by being active in the community, and softball is just the start.

Fairfield Township organizes and sponsors the adult baseball league, and 10 teams compete throughout the season to be in the final four teams that eventually make it to playoffs. There are many teams sponsored by businesses and individuals from the area. The league plays exclusively on the Hollywood End and Hollywood Main baseball fields in Fairfield, NJ, starting either at 6:15 or 7:30 p.m. We play next on the 18 at Hollywood End, June 25 at Hollywood Main and again on June 29 at Hollywood Main. On July 1 and 2, Fairfield Township is hosting fireworks shows that will be a sight to behold. After that, we play on July 8 at Hollywood End. Who knows, we may go to the playoffs! Don’t hold your breath for that though!

As you’ll see in the photo, our star pitcher and adept hitter is Derek J. Prince, son of our very own Dr. Daniel Prince whom attends the games with the team to provide support and motivation. We have the esteemed Timothy Parke on third base, and the great Joseph Paccagnini as our Short Field. Everything is brought together by our respected Coach and Captain, Mike Pannullo.

As you can see, our team looks excited to be in uniform and ready to play. We’re planning on a great season. Anyone underestimating our team filled with scientific prowess is sure to regret it! We might not be the leanest or the meanest team, but we’re probably the smartest! These pictures are from our first game, and this is our first time entering in the New Jersey Adult Softball league. We all had a great time on the field and are looking forward to really enjoying this season.

For us, it’s not about winning or losing, it’s about the experience, and showing our presence throughout New Jersey as something other than a group of scientists. Though we do place value on the reliability and quality of our service, we also want to show that it’s not all business for us—we want to help as community leaders. Even when we deliver a complete project for a client, we are doing it to better their organization and help provide for those who rely and depend on their project succeeding. Stay tuned for future posts about our community relations from Gibraltar Laboratories. We’re waiting on some photos from our 45th anniversary party and we’re looking forward to writing about that, too.

Daniel No Comments

FDA Auditing: Prepare Yourself With The Help Of Gibraltar Laboratories, Inc.

Proper testing is more important than ever.  Regardless of marketing and anything else, the only way to be fully compliant with the FDA is to have an effective drug.  Regardless of how powerful your fiduciary backing is and how prolific your marketing team is, without proper testing and research your product is as good as dust.

The FDA is constantly updating and auditing themselves along with anyone they do business with.  Their rules are strict, and their agents are the sharpest in the world.  Prepare yourself for the most rigorous and unforgiving inspections and auditing processes possible if you intend to have anything approved, period.

In November of 2014 alone the FDA was responsible for auditing, testing and approving dozens of products.  Check out this list about November 2014 on the FDA’s website.   Further observation of this data shows that many of these recorded approvals are for labeling revisions and manufacturing changes or additions.  Even after having a product approved, pharmaceutical industries need to be on top of researching drug efficacy as well as updating manufacturing facilities, keeping them within sanitary and other regulatory guidelines.

Finding the right CRO will mean the difference between approval or failed clinical trials.    Look at the FDA’s Introduction to New Drug Applications for Pharmaceutical and other research and medical device production organizations.  Approval doesn’t come easily, especially if your pharmaceutical company desires approval for orally administered drugs.  Pharmaceutical or otherwise, at some point in time a research organization will need to be either constructed or contracted.  Make no mistake—the NDA is comprised of hundreds of “guidance documents” that are reviewed with a fine-toothed comb by medical experts.  They don’t write themselves.

Prepare yourself for a wide range of submissions, applications, guidance documents, referrals, revisions, clinical trials, experiments and more.  Don’t forget that the most important part of production is making sure that the product is effective and safe to administer.  Sanitation and validation are as important as the product itself, as it ensures the safety of a medical product.

There’s nobody out there that wants their product to fail after passing rigorous clinical trials, because of impractical or ineffective storage and sterilization.  Proper validation of sterilization is integral to continued FDA approval of sterile products.  It’s imperative that every product is treated equally in the area of sterilization practices.

Between September and October of 1937 Elixir Sulfanilamide killed over 100 children in the United States.  It “tasted great”, but poor research allowed companies to market a deadly poison as cold medicine.  The FDA will never allow that to happen again.  Safeguard your institution by hiring a CRO like Gibraltar Laboratories, Inc.  Preparation for the FDA has never been more important.

Daniel No Comments

The FDA Regulates More Than Drugs, And They’re Always Debating.

Sometimes you have to review trends and watch the FDA in the media to really get an idea of how they think, react and constantly change.

On December 2nd, 2014, NPR (National Public Radio) reported that the Food & Drug Administration (FDA) was considering a revision on the blood donation ban that has been placed on homosexual males since the HIV discoveries of the early 1980’s.  The debate had taken place the previous Tuesday.

Gay rights advocates vehemently complain that the ban is discriminatory and does not take into account sexually promiscuous heterosexuals, intravenous drug users or prostitutes.  All of those parties are also at risk for HIV and not just homosexual males.

However, the FDA is an objective government agency. Its decisions are carefully considered based on decisions of scientific research and statistical evidence.

The FDA reasons that the high probability of homosexual males being infected with the HIV virus is reason enough to protect people depending on blood transfusions to survive.

And the media has been roaring awaiting their final decision.  There are even action groups starting to fight for the rights of gay and bisexual men who wish to donate blood.

So how could this change in the future?

Even now, Gibraltar Laboratories, Inc. works with companies that have breakthroughs in sanitation validation and microbiological testing.  Within shorter and shorter spans of times, analytical groups are capable of detecting microbiological threats in any substance, from blood to vaccines.

As these industries and technologies evolve, so do the possibilities.  In this modern age, soon possibly we could live in a world where anyone can donate blood and then have it tested rapidly, on the spot for any contaminants or diseases, instead of banning entire demographics due to risk factors.

Companies controlling and regulating blood donations in America could start contracting research organizations to test the blood that they receive for microorganisms and other contaminants.  This would ensure that regardless of who donated the blood, anything dangerous can be destroyed from the final product.

STD testing is already possible, but it takes time.  With the large volumes of blood that blood donation services deal with, it may seem like a daunting task, but with new technology and hopefully in the future, one simple drop from an entire sample will be able to identify threats, contamination and other present possible risk factors within any blood sample.

In the future, hopefully CRO’s such as Gibraltar Laboratories, Inc. will be playing a part in bringing the world to a new era where anyone can contribute, and risk factors are more of a statistic than a guiding factor.

Daniel No Comments

Challenges to Validation of a Complex Non-Sterile Medical Device Tray

BITThis scientific publication is an important case study. The challenges associated with demonstrating to a very high level of assurance of sterility are discussed in the context of case design, instruments, density, F0, maximum load configuration, minimum load configuration. In addition, the biological testing using qualitative and quantitative methodologies are illustrated.

The web address is, http://www.aami.org/publications/BIT/index.html

and in print

Challenges to Validation Of a Complex Nonsterile Medical Device Tray
Daniel Prince, Jozef Mastej, Isabel Hoverman, Raja Chatterjee, Diana Easton, and Daniela Behzad
Biomedical Instrumentation & Technology, Vol. 48, No. 4, July/August 2014: 306-311.
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“Microbiological Testing and Contamination Control – an opinion on the microbial limit test with reference to harmonization”

contractpharmaDear All,

Gibraltar Laboratories has published its 90th paper. The current issue of Contract Pharma has our article entitled “Microbiological Testing and Contamination Control – an opinion on the microbial limit test with reference to harmonization”. We are proud of the contributions of our technical services team to this effort: Christopher Waskewich, Kristah Kohan and Danina Rinaldi.  Our paper provides an opinion on the harmonization of USP microbial limits testing. It provocatively analyzes the changes that were made to USP Chapter <62> in order to win consent from the Europeans. You will find a copy  at https://www.gibraltarlabsinc.com/publications.html.

Daniel No Comments

GIBRALTAR IS THE NJ 2013 FAMILY BUSINESS OF THE YEAR: GOVERNOR CHRIS CHRISTIE

Dear Friends

Governor ChristieProcalamation

Gibraltar was AGAIN awarded with another prestigious award – the 2013 New Jersey Family Business of the Year Award!

This award is presented by the Rothman Institute of Entrepreneurial Studies at Fairleigh Dickinson University’s Silberman College of Business. The award was presented to Gibraltar Laboratories by New Jersey’s Governor Chris Christie at a ceremony on October 16, 2013.

Thank you for all of your continued support of Gibraltar Laboratories!

Daniel No Comments

Burkholderia cepacia and BCC – the next indicator organism?

BccHistory

The main interest in the presence of pseudomonads of any type (including Burkholderia cepacia complex (BCC) – the former Pseudomonas cepacia) is that they are strictly water-borne organisms (deionized water) which is used as the main ingredient in all of the medicaments listed in this report. Gram negative bacilli of this type thrive heartily in deionized water because of the sparse nutritional requirements.  Pseudomonas cepacia was first discovered by Walter Burkholder in 1949 while studying the cause of onion rot and gained more recognition in the 1980’s after it was found to cause a 35% death rate in cystic fibrosis patients that became infected, and subsequently was renamed in his honor.

Burkholderia cepacia is from a group of catalase-positive, lactose-negative, gram negative aerobic bacteria. Gram negative bacilli are divided into three biochemical groups based on their metabolism of glucose fermenters, non-fermenters, oxidizers.  E. coli, acaligenes and Pseudomonas/cepacia are examples of these three groups, respectively. They are motile due to a polar flagellum. Sometimes referred to as the Burkholderia cepacia complex (BCC) the group is comprised of B. ambifaria, B. anthina, B. cenocepacia, B. cepacia, B. dolosa, B. multivorans, B. pyrrocinia, B. stabilis, B. vietnamiensis and several others. BCC organisms are typically isolated from water, soil and agricultural products.

BCC organisms are naturally multi-drug resistant to many common antibiotics such as polymyxin B and aminoglycosides. There is a special agar called “Oxidation-fermentation polymyxin-bacitracin-lactose (OFPBL) that contains polymyxin (which inhibits most gram negative bacteria, including Pseudomonas aeruginosa) and bacitracin (which inhibits most gram positive bacteria as well as Neisseria sp.).  The presence of lactose distinguishes between fermenting and non-fermenting gram negative bacilli by rendering the medium yellow in the presence of lactic acid and bromthymol blue.

The microbe is able to remain viable for many months in harsh conditions such as low and high temperature extremes (12C to 48C) and in the presence of organic solvents, low nutrients, antiseptics, preservatives, antibiotics and preservatives. It has been found to survive for months in water (low nutrient) but for only maybe 1 week on a dry surface. Its ability to survive such conditions is due to its ability to produce a biofilm.

Over the years B. cepacia has become notorious for its ability to grow in the presence of the substances it is supposed to inhibit e.g., benzalkonium chloride in the barber shop and povidone-idoine antiseptics. A famous paradoxical case of antiseptic drug resistance occurred several years ago with the incident of pseudobacteremia where blood cultures grew cepacia but the organism did not come from blood – it came from contaminated PVP-I that was used to decontaminate the blood culture bottle.

Gibraltar recommends adding this organism to preservative challenge testing, disinfectant validations for facilities and USP <61/62> as our experience has indicated that it can be more resistant to standard preservatives than organisms in the current battery of USP methods. It can be noted though that finished product testing can yield false-negative results due to “nutrient shock” when using nutrient rich media. Special cultivation is necessary (pre-enrichment step) confirmatory identification.