BIG NEWS: SGS Acquires CSL 3 Jun 2019, 12:44 pm

SGS is now officially part of SGS North America!  We’ll now be known as SGS (SGS), and you’ll continue to receive the same level of service – and more – that you’ve come to trust and expect from CSL over the years.

On May 3, 2019, SGS formally announced the acquisition of CSL.  As per Frankie Ng, CEO of SGS, “This acquisition strengthens our Agriculture, Food & Life business in the U.S., further expanding our scope and geographical presence.”

As we’ve grown over the years, we’ve continually searched for the best means of expanding our offerings, without impacting our core business of trace elemental testing.  SGS distinguished itself as the clear choice for accomplishing that goal. ‘Not only could we offer SGS expanded capabilities with our trace elemental analysis,’ said Brian LaBine, SGS’s General Manger; ‘but moreover, SGS brought so many capabilities for us to offer our existing client base.  In the past, when customers have asked whether we could offer other services such as micro, organic, identity, pesticide, vitamin, SPF and other forms of testing, we’ve simply had to decline the opportunities. With SGS, we can offer those capabilities and more, while continuing our core business of metals and minerals analysis.’

For the SGS team, this translates to expanded opportunities.  SGS’ nearly 150-year history, operating platform in 160 countries with 2,600 offices and laboratories, financial strength and unmatched resources, all provide the foundation to bring long-term stability and opportunities for growth within our SGS family.  

It also allows SGS to leverage SGS’ considerable knowledge base – everything from upgrading our Environmental, Health and Safety systems/practices, to adopting global SOP and Quality systems, to unmatched libraries of technical resources and training programs, to the most extensive global regulatory know-how available.  ‘We were amazed to see what we can now offer our customers,’ said Francine Walker, SGS’s Technical Director. ‘With SGS’ regulatory platform, we can now assist even our smallest customers with regulatory guidance, regardless of where they wish to market their products.’

And for our clients, you should expect to see a gradual transition as we maintain our levels of service while integrating into the SGS network and expanding our offerings.  SGS prides itself on implementing a very pragmatic and systematic approach with integration of new companies. The names and faces will remain the same, but the offerings will expand over time as we fully integrate within SGS.

As with any change, many of our customers (or potential customers) will have questions along the way.  Feel free to contact us at any time – we’re always here for you! You may call us at (717) 697-7536, or if you prefer, send us an email at SGS_CSL_info@sgs.com.

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Happy 150th Birthday to the Periodic Table! 13 Mar 2019, 1:39 pm

“The periodic table is arguably the most important concept in chemistry” – Peter Atkins, chemist.

This month (March) marks a huge anniversary for chemists and chemistry lovers all over the world. 150 years ago, Russian chemist Dmitrii Ivanovich Mendeleev created the periodic table of the elements.

Mendeleev’s table has become a staple not only in our lab, but in the very science behind what we do here at SGS The periodic table summarizes an entire science into small squares containing letters and numbers that have become our lifeblood. It enumerates the elements and arranges them according to their properties, guiding chemical research both in theory and in practice.

Some say that Mendeleev conceived and created his table in a single day: March 1, 1869. As the legend goes, Mendeleev had been thinking about grouping the known elements for years. He, along with other chemists, knew links existed between atomic weights and chemical properties. However, it wasn’t until the 1860s that atomic weights had been well enough understood and measured.

As a professor at the University of St. Petersburg, Mendeleev was asked to teach inorganic chemistry. While preparing to master the field, he was not enlightened by the available text on the subject and decided to write his own. While organizing the text, he wanted to also organize the elements. The only question was: How best to arrange them?

By early 1869, Mendeleev had made enough progress on his book to realize that some groups of similar elements showed a consistent increase in atomic weights. He also realized that some elements with roughly equal atomic weights shared common properties.So ordering the elements by their atomic weight was his key to categorizing them. To keep them straight and organized, Mendeleev wrote each of the 63 known elements’ properties on an individual piece of paper. Then, he arranged the cards in vertical columns from lower to higher atomic weights, and placed elements with similar properties in each horizontal row.

And voilà: Mendeleev’s periodic table was born.

He sketched out his table on March 1, sent it to the printer and incorporated it into his soon-to-be-published textbook. He also prepared a paper to be presented to the Russian Chemical Society that same year.

Maybe even more impressive than creating the table in a day, was Mendeleev’s ability to predict undiscovered elements. During the preparation of his table with 63 elements, Mendeleev noticed that some spots were missing. He left blank spaces to be sure the known elements were properly aligned. Before Mendeleev’s death in 1907, 3 of those blanks were filled with the elements gallium, scandium and germanium. Not only had Mendeleev predicted the existence of these elements, but he had also correctly described their properties in detail.

Within the last 150 years, hundreds if not thousands of versions of the periodic table have been devised and published. The modern form as we know it (a horizontal design instead of Mendeleev’s original vertical design), became widely popular after World War II, largely due to the work of the American chemist Glenn Seaborg. Seaborg and his colleagues were responsible for discovering many new elements, including element 101. In 1955, Seaborg named the element “mendelevium”, for the chemist who above all others deserved a place at the periodic table.

For Prop 65 testing of metals in your product, please contact Chemical Solutions either by calling us at (717) 697 –7536 or submitting a request.  Either way, we’ll respond promptly to your inquiry.

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Milestone Features SGS in Case Study 15 Feb 2019, 5:00 pm

Recently, Milestone featured SGS in a Case Study highlighting how we use their equipment in our lab.

The study reviews the recent updates to USP <232>, <233> and <2232>, and how Milestone microwaves help us digest our high volume of samples. Read more here: Case Study-Chemical Solutions-USREV021119

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The Future is…BIGGER! 16 Jan 2019, 3:00 pm

Even after moving to our current location in the fall of 2015, we’ve had dreams of expanding CSL’s borders- literally. With the new year upon us, we’ve began the process of renovating the front of our building into a new space for our employees and visitors.

Here are pics of the new front area after the demolition took place. We’re now ready for the contractors to come in and help us transform the space into something functional and beautiful!

The project represents the opening of 50% more space (than our current footprint) for eventual lab, office and meeting work spaces. We will also be converting our existing storage area into lab offices, for our analysts’ use.

Follow us on Facebook, Twitter and LinkedIn for future project updates and eventually, the BIG REVEAL!

And as always, for testing of metals or minerals in your product, please contact Chemical Solutions either by calling us at (717) 697 –7536 or submitting a request.  Either way, we’ll respond promptly to your inquiry.

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2018 in Review… Counting Our Blessings 19 Dec 2018, 9:25 pm

Yes…another of those ‘Year in Reflection’ blogs! While self-promoting in nature, it also gives us time to share the happenings at CSL with many of you, and to extend our sincere thanks to you, our clients, who entrust your testing with us and allow us to exist.

2018 was the ‘Year of USP!’…and more.

With USP <232><233> becoming effective on January 1st, we saw method validation, verification and screenings continue throughout the year, as we assisted Pharma clients with their risk assessments pertaining to Elemental Impurities. Over the past 3 years alone, CSL has conducted over 1,400 spike screenings, method validations and method verifications for the Pharmaceutical industry. That’s a lot of digestions!

The USP general chapter changes also affected our Dietary Supplement customers, in that USP <2232><233> also became effective at the beginning of the year. While USP<2232> is voluntary in nature, USP <233> defined the method by which Dietary Supplements should be tested. The ‘USP Seal of Approval’ also provided a more visible measure by which clients could publicly display their commitment to quality standards, and CSL was able to help many by conducting screenings and validations of finished products and raw materials alike.

Personal Care Products and Cosmetics testing also grew over the course of the year, thanks to our clients who gave many references to others in the industry who were seeking out qualified labs to test both active ingredients as well as impurities (roughly 40% of our new clients come to us via referrals!). CSL expanded its public presence in this market by participating again in both the NYSCC and PCPC conferences.

Internally, we added fun stuff like new Auto Digesters, Auto Samplers, a Trace Clean vessel cleaner, line conditioners, and yet another ICP-MS instrument. Not particularly exciting for our ‘non industry’ friends, but downright exciting for folks like us!

Of course, instruments need people to run them, and we added to our team there as well (see Holiday Photo for evidence!), bringing our total CSL family to 38 strong. We’ve all heard the dull drone of the CEO saying ‘Employees are our greatest asset.’ Well, this CEO will say that as well, but hopefully without the dull drone – our people rock…and, every day they make the instruments sing, the digesters digest, get your samples entered and reported correctly, let you know where the heck your samples are in the process, and answer your questions – promptly!

We never stop wondering at the marvel of a company – and our company – and the role it plays in providing a service to our customers, while providing a living for our people. Without the trust of you, our customers, none of this happens. So from the bottom of our hearts – thank you.

Enjoy the time with family and friends over the holidays, and here’s to a wonderful New Year!

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The Benefit of Interlaboratory Studies 21 Nov 2018, 1:01 pm

Product testing and compliance have both been a recent topic in the news, particularly in regards to the safety of consumer products in both the pharmaceutical and dietary supplement industries. It has brought to light a question to many consumers: Are these companies even testing what they produce?

In reality, companies in these industries have a variety of choices when it comes to choosing a testing laboratory to send their products. There are options such as full-service labs, specialty labs, local and international labs, or even setting up an internal lab on site.

Chances are that if you’re familiar with product testing, you’re currently happy with the laboratory choice you’ve made. But here’s a thought: How do you know the lab you’re using is providing you with good data?

Try an Interlaboratory Study

The first thing most companies look for when considering another lab is if the lab is “accredited”. Sure, a list of accreditations the lab possesses is impressive, but accreditations don’t necessarily speak to a quality of a lab. They simply tell you that a lab has a system in place that meets some sort of recognized standard.

We suggest to periodically check lab results with another lab, which simply means conducting an interlaboratory study. When comparing two separate lab results head-to-head, you’ll be made aware of any discrepancies that may be occurring in the current analysis.

On the flip side, it can also confirm your results if they are ever questioned by an outside regulatory agency. Regardless of the outcome, this comparison will help your company better understand the beginning-to-end process your choice lab is using to analyze your products.

An interlaboratory study will ultimately give you the confidence and peace of mind that data you are receiving is accurate and correct. This is especially important for those companies that are relying solely on their in-house lab results.

Additional Measures

Some labs have additional quality checks in their operating procedures to ensure that the data that is being produced is as accurate as possible.

One of the options CSL offers is a method validation specific to our clients’ unique sample matrices. While these validations vary by client and product, they all generally include analyzing replicate samples and matrix spikes through our full analytical process at varied amounts and conditions to verify the method’s reproducibility, detection limits, ruggedness, etc.

Other quality checks CSL utilizes:

• A strict quality assurance program – Our procedures and documents are available during on-site audit. These include: sample control documentation, individual analytical methods, analyst training, equipment preventive maintenance, calibration, corrective actions, internal quality control activities, data validation, and data reporting.
• Matrix spike samples – At CSL, we include at least one matrix spike per ten samples. A matrix spike is created by adding a known amount of the element(s) to be tested directly to the sample. We analyze the sample and the matrix spike independently and assess their ability to recover the added spike from the sample.
• Proficiency Testing (PT) samples – PT samples are materials which contain target analytes (like lead, cadmium, etc.) which we purchase through regulatory agencies as a part of our accreditation protocols. The amount of each analyte in a PT sample is known only to the provider and is not made available to us. We analyze this type of sample as part of our normal routine, and report the results to the PT provider.
• Commercially prepared reference materials – Standard Reference Materials (SRMs) are substances which are homogeneous and contain well established analyte amounts. These materials are verified by several laboratories using different analytical techniques so that they can be confidently used to calibrate instruments or assess the accuracy of an analytical method. We use commercially prepared SRMs to help assure the accuracy of our methods, such as instrument calibration.
• The use of “blanks” – Because our main focus is on heavy metals analysis, we are often quantitating elements in the microgram and nanogram range. At levels this small, we need to ensure no contamination is occurring during the course of sample preparation or analysis. We use method blanks, which are samples that do not contain the element of interest. The blank is treated like a sample in terms of processing, so any contamination which would affect the samples should be evidenced in the analysis of the blank.
• Interpreting lab results – We say it often, but our customer service is top notch. We’re proud of the fact that our staff is always able and willing to help a client answer any and all question they have regarding lab results. In situations that require more explanation, we realize the importance of our clients understanding the numbers on a report so they are then able to explain it to others.

Choose us as your back up!

Choosing CSL to be an “alternate lab” eliminates the scramble to qualify a new lab whenever disruptions may occur. Our quality, capability, and experience make us your top choice for an alternate lab. Once CSL is qualified for your company, we’ll be ready to assist when instrument failures, disputes, or poor service occur with your current lab of choice.

For testing of heavy metals or minerals in your product, please contact Chemical Solutions either by calling us at (717) 697 –7536 or submitting a request.  Either way, we’ll respond promptly to your inquiry.

Reference: The “Heavy Metal Analysis and Interim Recommended Limits for Botanical Dietary Supplements: White Paper”, published in January 2009 by the American Herbal Products Association.

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Gummies and Chocolates and Mints, OH MY! 1 Nov 2018, 3:29 pm

After being in business for over 21 years, we see thousands of samples come through our doors. One of the more interesting (and delicious) type of sample is the candy our clients send us to test.

We’ve seen everything from fruit-flavored gummies to chocolate to peppermints- and all for good reason.

Candy Concern

In 1994, a high amount of lead was detected in an imported candy product. Because children are the main consumers of candy, many people were concerned about the manufacturing and packaging processes of all varieties of candy. This led the FDA to put more precautionary guidelines into effect to address the questions that were being asked.

Was the lead coming from certain ingredients? Was it from the machines used to make the candy? The wrappers they were enclosed in? You can read more about the FDA guidelines here.

Since then, companies that manufacture and distribute candy have the ability to choose to test everything that touches the process, from the ingredients they use to the very wrappers they choose.

Digesting the Deliciousness

Our laboratory uses several techniques in order to digest tougher samples like gummies and peppermints to prepare them for analysis. Through the addition of acid and heat (with the help of automated digestion systems and microwaves), we can mimic a similar environment the candies would eventually end up in- our stomachs! Once the candies are completely digested and in solution, we properly dilute them so they are ready for ICP analysis.

We’re Here to Keep You Safe!

Here at SGS we’re in business to serve you and your customers. Keeping consumers safe and healthy is our number one priority, and we love doing it! By staying up to date with FDA guidelines, you too can ensure that your products go through the proper and necessary testing steps before your products hit the shelves.

On behalf of the SGS team, we wish you a very Happy and SAFE Halloween!

For testing of metals in your food or beverage products, please contact Chemical Solutions either by calling us at (717) 697 –7536 or submitting a request.  Either way, we’ll respond promptly to your inquiry.

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CSL Adds USP to Repertoire of Testing 10 Oct 2018, 8:25 pm

In response to the most recent revision for USP <1660> Evaluation of the Inner Surface Durability of Glass Containers, SGS has taken the lead in optimizing, validating and supporting the newest recommendations of applying the ICP impurities testing portion of the standard to meet current guidelines.

What’s the big deal?

The presence of glass flakes in a solution is a strong indication of the interaction between the drug product and the inside surface of the glass container. Delamination is defined as the separation of thin, sharp flakes of glass particles from the interior of a glass container. This occurrence is responsible for numerous pharmaceutical product recalls (like this) and is a serious issue when it comes to quality.

Many factors influence the durability of a glass container. These include: the composition of the glass, the coating of the surface, the temperatures at which annealing is performed, storage conditions of the glass, the drug substance inside the container and the shelf life of the drug itself.

In the past, one of the best ways to test for delamination was through the use of SEM. Scanning Electron Microscopes allows the user to view & confirm the presence of glass flakes within a liquid, proving delamination has occurred. However, this method is a reactive analysis that can only be confirmed once the flakes have broken off the container and are freely suspended in the solution.

In the recently updated USP <1660>, the chapter highlights a more proactive approach to ensure compliance with cGMP practices. It is recommended for drug manufacturing companies to perform stability studies and glass delamination testing.

How does CSL test for this?

One of the most critical evaluations of determining the suitability of a given glass container for a specific product is the potential increase of silicon dioxide concentration in the drug product over normal stability or when subjected to accelerated conditions. The formulation of a silica-rich layer poorly bonded to the substrate is the first stage of an extended delamination. Glass-liquid interactions are responsible for the formation of an altered later, which leads to swelling and cracking and the release of glass within the substance. This portion of the overall testing evaluation combined with the additional recommended testing methods, provides valuable information of the potential of a drug product to cause formation of glass particles and delamination of the inner glass surface.

CSL uses robust methods to accurately determine the concentration of Silicon in drug product or other appropriate matrices.  These methods satisfy the requirements of USP <1660> ICP-MS testing and provide the critical information needed for product development and non-conformance investigations.

The Bottom Line

The responsibility to ensure the safety and integrity of a product in a glass container is placed solely on the drug product manufacturer, not the vial manufacturer. Because each matrix will react differently over time and in differing conditions, it’s important to understand the significance of the mechanism that’s occurring within the vial. Whether you are proactively testing to determine if a vial is compatible with your product, or reactively responding to an FDA non-conformance letter, SGS will help you assess your drug product.

For testing your product, please contact Chemical Solutions either by calling us at (717) 697 –7536 or submitting a request.  Either way, we’ll respond promptly to your inquiry.

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Explaining the “Naturally Occurring” Exemption in Prop 65 19 Sep 2018, 4:00 pm

The updated Proposition 65 requirements have been one of the most-discussed topics in the natural products industry in 2018. Since you’ve heard about them so much, you probably have them memorized. You know that businesses are required to provide “clear and reasonable” warnings on products that expose consumers to any of the 900 chemicals listed. You’re familiar with the safe harbor levels that the heavy metals must meet to prove “no significant risk level” (if not, check here: Prop 65 levels). But are you aware of the exceptions for naturally occurring chemicals and elements?

Explaining “Naturally Occurring”

Section 25501 of the Proposition 65 regulations specifically relates to foods and dietary supplements. The Office of Environmental Health Hazard Assessment (OEHHA) exempts the exposures of chemicals and elements in foods that are found to be “naturally occurring” and are present in the “lowest level currently feasible.”

“Naturally occurring” chemicals and elements are those that exist in food as a natural component. In other words, their presence in a food or crop is directly a result of its absorption or accumulation in the environment in which it is grown or harvested.

In relation to Prop 65, the “naturally occurring” amount of a chemical or element in that particular food can be subtracted from the total amount of the chemical in the calculation of exposure levels.

However, this is easier said than done.

It is important to understand that a chemical or element is naturally occurring only if it is not generated by any human activity. To prove this, suppliers must show that the existing natural levels of that chemical or element are directly affected by the area in which the food is obtained. This can be done by specific analyses, but depending on the location of where the food is grown, it can be almost impossible to perform. Food providers must also show that the chemical or element will occur naturally in the food, despite their best efforts of safe food practices to avoid them. Quality controls must be used to maintain the “lowest levels feasible” of the listed chemical or element.

Lead: The Leading Culprit

Possibly the most cited element in Prop 65, lead has more violations than any other element listed. This is probably because of the frequency it occurs in nature. Low doses of lead have been found in the soil, plants or water used in food, herbal and dietary supplements production across the industry.

Lead has been named a reproductive toxicant, so Proposition 65 warnings are required on labels for exposures of more than 0.5 μg/day. This safe harbor level of 0.5 μg/day is considered significantly lower than the amount of lead in normal daily serving sizes of fruits, vegetables, and herbs.

The Exemption

This leaves it up to the company supplying the food to demonstrate that the level of the lead is “naturally occurring”. If they can prove this, they are “exempt” and can avoid the warning requirement for levels exceeding 0.5 μg/day for lead.

If you are on the fence about testing your ingredients or food products, it’s better to err on the side of caution and have it tested. SGS is your trusted third party laboratory with over 20 years of experience in the food and dietary supplement industry.

For Prop 65 testing of metals in your product, please contact Chemical Solutions either by calling us at (717) 697 –7536 or submitting a request.  Either way, we’ll respond promptly to your inquiry.

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Evolving from the 100 Year Old USP Method to USP 29 Aug 2018, 6:07 pm

Many of our clients are concerned because they are not sure how they should implement the Permissible Daily Exposures (PDEs) laid out in the new USP guidelines. We discuss unique routes of administration and unlimited serving sizes on a weekly basis. But the most common issue is how to “update” the use of USP <231> limits to the guidelines published on January 1, 2018.

For clients who have historically used the USP <231> method, the question becomes how to integrate the summation limit of the ten heavy metals (Ag, As, Bi, Cd, Cu, Hg, Mo, Pb, Sb & Sn) into the current PDE calculations. We now use whichever is lower:

• 1/10 of the total HM specification for each individual element. For example: If the summation of the HM must be <10 ppm, this would equate to 1 ppm for each element.  

OR

• The USP <232> Oral Daily PDE for the element, divided by the serving size. For example, let’s use mercury’s oral PDE of 30 ug/day. If a product’s serving size is 2 grams, the specification becomes 30 ug/day divided by 2 grams, giving a specification of 15 ug/g or 15 ppm.

In this case, we would default to the top calculation of 1 ppm for the mercury specification in this product.

To view USP <232> limits, click here.

Note: For products with smaller serving sizes, the specifications for elemental impurities may change once you are dealing with USP <232/233>. For example, PQLs can increase dramatically, particularly with small serving sizes.

For USP testing of your product(s), please contact us at (717) 697–7536 or submit a request here.

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