Derek Prince No Comments

FDA FINAL RULE: Consumer Antiseptic Washes Are Neither Safe nor Effective.

 

FDA FINAL RULE: Consumer Antiseptic Washes Are Neither Safe nor Effective.

Written by: Derek Prince

On September 6, 2017 the Food and Drug administration (FDA) final rule banning a list of 29 consumer antiseptic wash ingredients officially became in effect. This rule strictly bans the usage of certain ingredients commonly used in the manufacturing of products intended to be applied and rinsed off with water.  It should be noted that this final rule has no effect on the manufacturing of consumer antiseptic rubs, commonly referred to as “hand sanitizers, “hand rubs” or “antibacterial wipes”. Similarly, this rule has no bearing on health care antiseptics, first aid antiseptics or antiseptics used in the food industry.

Although certain ingredients were temporarily deferred from this ruling, it is most likely only a matter of time before all consumer antiseptic wash products are banned.

Because of the stimulation of interest that the new rule has and will engender, Gibraltar has composed a paper on aspects of antiseptic science and have chosen to discuss four antiseptics of the many presented in the Federal Register. If you’d like to learn more about this topic and some common antiseptic/disinfectant ingredients we encourage you to get a copy of the article: “A review of consumer antiseptic wash ingredients undergoing FDA challenge” published in the Contract Pharma – September 2017 print and online edition. The digital version can be viewed by following the link below:

https://www.contractpharma.com/contents/view_features/2017-09-06/fda-otc-antiseptics/

 

Danina Rinaldi No Comments

Discussions about Total Organic Carbon

Discussions about Total Organic Carbon

By Danina Rinaldi

Testing bulk, sterile, purified, DI, or sterile water for pharmaceutical purposes is important for manufacturing, production and analytical applications.

Total organic carbon, or simply TOC, provides an indirect measurement of all the organic molecules in a water sample. The test method is very sensitive, providing results in ppb (parts per billion).  A major advantage to in using this test is that it accurately quantifies most organic materials that may be present in only trace amounts. Accordingly this methodology is well suited to verify cleaning in between manufacturing campaigns.

Because of its advantages TOC is one of the tests considered to be most critical for final water quality per the USP chapter <1231> Water for Pharmaceutical Purposes.   It is purposed to provide critical feedback to determine product quality and performance as well as immediate use and suitability.

In addition, there are many examples in the USP that require this test to be performed as a quality attribute. For example, Pure Steam, Water for Injection, Sterile Water for Inhalation, Sterile Water for Injection, Purified Water, Sterile Purified Water and Water for Hemodialysis.

Other USP general chapters containing requirement for this test to be performed  are <1051> Cleaning Glass Apparatus, <1059> Excipient Performance, <1661> Evaluation of Plastic Packaging Systems and their Materials of Construction with Respect to their User Safety Impact, <1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems, <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use.

When submitting samples, sponsors should be careful to note that the use of plastic materials may contribute to the TOC levels.  Other contaminating factors may be presence of alcohol or detergents and microbial contaminates.  The total organic carbon test is not a substitute for a routine microbiological monitoring practice.  To monitor the microbial quality of water a heterotrophic plate count and coliform tests are necessary to be performed.

Samples should be sent refrigerated, overnight in a 40 ml I-Chem Low Level Certified Vial.

Contact Gibraltar Laboratories, Inc. to begin testing today or for more information click here.

Kate Slezak No Comments

Why Should You Change Your Contacts Often?

Why Should You Change Your Contacts Often?

Written by Kate Slezak

These days, it’s safe to say that everyone either wears contact lenses or knows someone who does and understands that it’s important to change your contacts frequently. As if it isn’t annoying enough to have to dig your fingers into your eyeballs each morning and night, you also have to stay on top of keeping the contact solution fresh and the supply of new contacts steady. Regardless of whether someone has one-day-use or another type of contacts that can be left in longer, doctors warn of the importance of switching pairs regularly. But why change them so often? Why not just save money and wear the contacts a little longer, especially if they aren’t scratched? Is it really so bad to have irritated eyes for a few days?

Irritation is not the only effect of leaving contact lenses in too long- it can also lead to the growth of an organism called Pseudomonas aeruginosa. Though P. aeruginosa primarily affects patients in hospitals or with weakened immune systems, it can also cause problems in healthy patients, like rashes on the skin when hot tubs are inadequately chlorinated and eye infections with extended-use contact. Only requiring acetate and ammonia as its source of carbon and nitrogen, P.aeruginosa is an opportunistic pathogen, meaning it can easily adapt to survive in many different environmental conditions and can make use of a wide range of available nutrients. Though it commonly affects plants like lettuce, tomatoes, and tobacco, P.aeruginosa forms slime-enclosed communities called biofilms that allow it to survive and grow within human tissues. These biofilms prevent antimicrobial agents and other antibiotics from entering the community of bacteria within. This form of defense allows the organism to be resistant to antimicrobial agents found in hand creams, and certain cleaning solutions, like those in contact solutions.

Irritation from wearing contact lenses for an extended period of time can lead to inflammation and infection, called microbial keratitis. Though many bacterial organisms’ growth can lead to microbial keratitis, the most common source is P. aeruginosa. Once in the eye, P. aeruginosa has the ability invade and kill corneal cells. It can also activate several pathways in the immune system which are used to alert the body of the source of inflammation and recruit white blood cells. Despite the fact that white blood cells usually fight infection within the body, the buildup of white blood cells can lead to the destruction of healthy corneal cells and other tissues within the eye, ultimately leading to scarring and vision loss.

Pseudomonas aeruginosa is not only responsible for causing eye irritation from the use of old contacts, it also has the ability to withstand varying environmental conditions with minimal nutrients allowing it to grow and multiply in environments practically devoid of nutrients. This includes distilled water and anaerobic environments, as well as those with higher temperatures of up to 42°C (107.2°F). The elevated temperature levels and churning water of hot tubs causes the chlorine levels in the water to drop and allow the resulting higher pH of the water to reduce the antibacterial effect of the halogens in the chlorine. If the chlorine level drops below <1mg/L P. aeruginosa  can multiply up to 1,000,000 organisms per milliliter of water in as short a window as 24hours. The organism can enter the body through the gastrointestinal tract due to the accidental ingestion of water and spread to warmer moist areas of the body, like the perineum and armpits, and form a rash.

Laboratories like Gibraltar Laboratories use the antimicrobial effectiveness test to test the antimicrobial properties of hand creams and optic solutions such as contact solutions over time. This helps to prove how strong the antimicrobial agents in these products are in preventing the growth of harmful bacteria like P. aeruginosa. Though there are antibiotics like fluoroquinolone that can be used to combat P. aeruginosa, the organism is known for its ability to resist antibiotics and to even mutate to survive once an antibiotic has already been introduced. That being said, it’s not a pleasant organism to contract.

So the doctors are right- spend the extra money and make sure you and your friends aren’t keeping contacts in for too long and are changing the solutions regularly.

 

References:

Breidenstein, E. B., De la Fuente-Nunez, C., & Hancock, R. E. (2011, August). Pseudomonas aeruginosa: all roads lead to resistance. Trends in Microbiology, 19(8), 419-426. doi:10.1016/j.tim.2011.04.005.

Crnich, C. J., Gordon, B., & Andes, D. (2003, February 1). Hot tub-associated necrotizing pneumonia due to Pseudomonas aeruginosa. Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 36(1), 55-57. doi:10.1086/345851.

Fujitani, S., Moffett, K. S., & Yu, V. L. (n.d.). Pseudomonas aeruginosa. Retrieved August, 2016, from http://www.antimicrobe.org/new/b112.asp.

Klockgether, J., Cramer, N., Wiehlmann, L., Davenport, C. F., & Tummler, B. (2011, July 13). Pseudomonas aeruginosa genomic structure and diversitty. Frontiers in Microbiology, 2(150). doi:10.3389/fmicb.2011.00150.

Pseudomonas aeruginosa in Healthcare Settings. (2013, April 2). Retrieved August, 2016, from http://www.cdc.gov/hai/organisms/pseudomonas.html.

Schaber, J. A., Triffo, W. J., Suh, S., Oliver, J. W., Hastert, M., Griswold, J. A., . . . Rumbaugh, K. P. (2007, August). Pseudomonas aeruginosa forms biofilms in acute infection independent of cell-to-cell signaling. Infection and Immunity, 75(8), 3715-3721. doi:10.1128/IAI.00586-07.

Wilcox, M. D. (2007, April). Pseudomonas aeruginosa infection and inflammation during contact lens wear: A review. Optometry and Vision Science: Official Publication of the American Academy of Optometry, 84(4), 273-278. doi:10.1097/OPX.0b013e3180439c3e.

Daniel Prince No Comments

Gibraltar Laboratories Heritage- “The Journey” By Dr. Daniel Prince

Gibraltar Laboratories Heritage- “The Journey” By Dr. Daniel Prince

My role at Gibraltar now involves looking to the future as I begin to ponder a transition towards a lesser role and eventual retirement. I am busy leading our succession planning and developing the future leaders of organization. My greatest wish is for Gibraltar Laboratories to continue in the future without me and still  be known as the excellent company it is even while it increases its market share and diversifies its offerings.  I invite you to view a short video that is a rare example of three generations of a scientific contract testing laboratory, all being featured at the same time about their feelings on the company.

Even as I look forward I also remember my beginnings at Gibraltar. As a family operated business I was fortunate to gain employment and work under my father, Dr. Herbert Prince. He and my mother, Leah Prince, BA, established our company at great risk and his  superior knowledge of bacteriology, virology, chemistry and toxicology provided a strong foundation and wide breadth of services to offer to pharmaceutical, medical devices and cosmetic companies. I was trained by my father and I learned a lot on my own working many hours for many, many years — even today. When my dad decided to retire he consulted with a professional firm to guide him about selecting his successor. At that time my two younger brothers were also working at Gibraltar. Fortunately, after about a 1½ years process, I was selected to be the president.

Now my son Derek Prince, MS, is completing a Ph.D. to prepare him with the same strong scientific heritage of my father and myself. I need to assure that he is properly prepared. I am so proud to work beside him and see his vision of the company through his enthusiastic eyes.

Working at Gibraltar for almost 40 years I can honestly say it has been a privilege to work with my parents and many other family members including Derek. The video I mentioned is very special because it lets you, our customers, employees, colleagues have a glimpse of our family’s story — The Gibraltar Labs Journey through three generations. A story involving three generations of management all holding scientific Ph.D.’s. I hope that this video will inform our customers and employees about the history of our company and the journey we have taken to become the highly respected organization that we are today. Please leave a comment about the video or something about Gibraltar that you can share.

 

Daniel Prince, Ph.D.

President

 

Kate Slezak No Comments

Importance of Microbiological Food Safety Testing

Importance of Microbiological Food Safety Testing

Written by Kate Slezak

When we first start going to the grocery store with a parent or family member, we all get taught the same things; don’t get the expired milk, check the tomato for bruises, don’t take the dented or bulging cans. Some things are straightforward – no one wants to eat a rotten tomato or suffer the nasty stench of curdled milk, but why avoid the bulging cans? Who decided that was a thing we had to do? Does it not mean that it’s just stuffed with extra food? People throw around the word “Botulism” but what does it mean?
Clostridium botulinium, the organism that causes Botulism, leads to problems in the nervous system that may result in muscle and chest weakness, difficulty seeing, and can even be fatal. It’s considered a thermophilic anaerobic organism, meaning it can withstand extreme temperatures and mostly exists in environments without oxygen. But it’s only one example of the different thermophilic anaerobic organisms that affect the food consumers purchase on a daily basis.- There are some foods and contaminants that people aren’t even aware of, and most people don’t know where it all comes from. Here at Gibraltar Laboratories, Microbiological Food Safety Testing is performed in order to detect thermophilic anaerobic microorganisms similar to that which causes Botulism. These types of bacteria and spores are responsible for 60-80% of the spoilage of canned foods, and can present problems in things like infant formula, dehydrated milk, starch, flour, cereals, soy proteins, and even sugar.
Contaminants like the spores we test for usually grow on the handling equipment throughout the canning process, the skin of the handlers, in the soil, and on the raw materials themselves. The affected foods can be contaminated at several points during processing. For example, many canned foods such as vegetables and meats go through a process of sterilization that involves the use of extreme heat. This heat is used to hermetically seal the product and kill any bacteria incapable of withstanding such temperatures, thus making it safer for consumption. The cans are then cooled by being placed in water, which despite often being treated with chlorine to prevent bacterial growth, is the source of most canned food contamination. Organisms growing in the cooling water can leak through any failing hermetic seals due to dents in cans or an incorrect sealing process, contaminating the food within. In the case of infant formula, if thermophilic organisms are present in the raw milk, the high temperatures attained during the pasteurization process can cause the spores to grow and contaminate the formula.
A shopper can sometimes avoid buying these contaminated foods by doing what we were taught to do- avoid swollen or dented cans. Many of the thermophilic anaerobic spores and bacteria that contaminate canned food produce carbon dioxide and hydrogen, which react with the acids in the food and the metals in the can, causing it to swell and indicating that contamination is occurring. On the other hand, some organisms don’t produce gas or are packaged differently. This makes it much more difficult for the average person to find contaminated products like sugar or cereals, which are sold in boxes and bags. That’s what the FDA and laboratories like Gibraltar are here for. Companies will check their finished products by performing routine Microbiological Food Safety Testing with Gibraltar Laboratories, Inc. to keep consumers safe. The FDA enforces strict rules and methods of detection that Gibraltar uses to test products such as infant formula, starch, flour, cereals, and other related products for all of those hard-to-see contaminants that can hide in food and make you sick.
So Mom was right- avoid those swollen or dented cans, but we’ll are here to help make sure what you’re consuming is safe. For more information on our testing services and how our microbiological food testing services as well as our sterilization services can help your business contact us today at 973-227-6882.

Daniel No Comments

Gibraltar Laboratories Receives ACIL Customer Quality Service Award

We’re excited to announce that we have received confirmation that Gibraltar Laboratories has received the ACIL Customer Quality Service Award for the fourth year in a row!

The American Council of Independent Laboratories (ACIL) has been awarding the ACIL Customer Quality Service Award on a yearly basis since 1996. The purpose of the award is to provide a system with which to evaluate laboratories and compare the quality of their operations. It’s the only program in the laboratory services industry that both ranks customer satisfaction as well as requires the participating laboratories to commit to a data integrity program.

During the evaluation process, participating laboratories provide customer satisfaction surveys to their clients, as well as deliver proof of their annual ethics-training program, systems designed to detect suspicious analytical practices early on, and a code of ethics the laboratory has agreed to. The 2015 round of evaluations was highly competitive, as the participating laboratories had an average of 3.5 out of a possible 4.0 in the timeliness category, and an average of 3.7 out of a possible 4.0 in the overall customer satisfaction category.

Despite the high standards and expertise of the laboratories participating, in addition to being awarded the ACIL Customer Quality Service Award, for the fourth year in a row Gibraltar Laboratories was also ranked in the top fifth of the participants for both timeliness and overall customer satisfaction. We’ll be heading over to sunny Florida to accept our award at the ACIL Annual Meeting that takes place from October 6th to October 9th.

We believe that our consistent success with the ACIL Customer Quality Service, as well as other recognitions we’ve been awarded and our reputation for excellence, are a direct result of everyone at the company committing to the principle of outstanding customer service. We at Gibraltar Laboratories have high standards for our staff, only hiring the most experienced and motivated experts in the field, and we are extremely appreciative of their hard work and dedication that makes us one of the leading testing laboratories in the country.

Moving forward, we want to continue to live up to our mission and quality policy statements, not only upholding, but ever improving, the quality of our operations, facilities and customer service. We believe you can’t be one of the best providers of a large variety of services from rapid sterility testing to medical device cleaning validation without constant diligence and willingness to go above and beyond to find the right solutions for every one of our customers.

 

Daniel No Comments

Why We’re A Great Organization To Work For

At Gibraltar Labs, we’ve enjoyed success throughout our long history. Our talent is key to our success! Now we are looking to expand and find new team members to bolster our already award winning team. That’s why we have so many career openings right now at Gibraltar Labs! There are many reasons to work for us, and we want to talk about what those reasons are, and why we’re a great employer to consider.

We’re Trusted

Over the years, we’ve become trusted throughout the world of microbiological testing, including sterilization services, virology, toxicity testing, bioburden testing, endotoxin testing and more. Our laboratory features the latest technology with all of our departments headed by extremely knowledgeable master and doctorate-level scientists with both academic and industry experience alike.

We’ve Earned Our Place

We’ve been around for over 40 years, earning us an exceptional reputation for both the quality of our work and the way we do it. We only accept the highest level of exceptional customer service and we treat our employees with the same respect that we do our clientele—that is how we’ve earned such a trusted spot among contract testing organizations.

We provide quality research through our roughly 40,000 square-foot laboratories in Fairfield, New Jersey. Our track record for high quality research and results for our clientele have brought in over sixty papers and/or publications in trade literature and peer-reviewed scientific studies. We have extensive connections and professional relationships with high-ranking individuals in the FDA, EPA and USP. We’re also involved with major trade organizations including A2LA, AAMI, NJPQCA and more, carefully complying with all regulations therein, delivering only the most compliant, highly diverse products for our clientele nationwide.

We’re Diverse

There are many companies you can join that do one, maybe two different things within their scope of service. At Gibraltar Labs, we are extremely diverse, accommodating a wide variety of industries and organizations. We’re well known for our services related to the pharmaceutical and drug development industries, and have processed numerous successful new drug applications and assisted with many successful clinical trials. We also service the medical device industry providing sterilization, sterilization validation including rapid sterility teating and many other related services. Tissue banks, biopharmaceutical professionals, chemical engineers and cosmetic industries trust our expertise as they are developing their products and carefully maintaining their sensitive materials and samples.

We’re Fully Registered and Recognized.

We’re fully registered with the FDA, and we’re ISO 17025 certified, meaning that our laboratories hold up to the strictest standards outlined by the American Association of Laboratory Accreditation. We value teamwork, positivity, respectful attitudes, personal growth, excellence and passionate people. We received the New Jersey Family Business of the Year Award in both 2013 and 2014.  We’re family owned and our management staff is hands-on and well-educated in the fields that we practice. Instead of having a team of scientists lead by businessmen that aren’t accommodated with science at all, we’re a team of top-notch scientists and industry experts, which is why our clients understand that their project is in the best hands it could ever be in.

Please don’t hesitate to apply! We are always hiring open-minded and passionate team players. Check out what we have to offer at https://www.gibraltarlabsinc.com/careers-at-gibraltar.html. You can learn more about our company by browsing our website and seeing what we have to offer. We look forward to hearing from you, and thank you for visiting Gibraltar Laboratories.

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

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.
Daniel No Comments

“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.