With pressure to get new products to market, companies are faced with meeting rigorous standards and the time consuming development and testing to make their products market ready. Since the development process is time consuming, taking from months, up to years, there is no doubt that outside, unbiased help could be beneficial. When faced with deadlines, companies turn to contract laboratories to meet their needs.
When developing products, companies stick to what they know, or their core competency. “Most of our customers focus on their manufacturing core competencies, or better known as their expertise,” says Michael Robinson, Director of Business Development, Stork Materials Technology, Amsterdam, NL . “Whether their core competency is machining a part, welding a part, fabricating, design development, assembly, casting or forging, companies put their money in those directions, and outsource what is not their core competency.” Companies stray away from doing testing and development that is not within their expertise, and search for a contract laboratory that holds the expertise of what the company lacks, helping them move closer to their overall goal of getting the product to market.
However, core competency is not the only issue that drives companies to outsource. Another is cost effectiveness. With the slump of the U.S. economy, it is an unreasonable notion for a small, or even a large company “to purchase, or maintain, a $150,000-$250,000 piece of equipment if it is only going to be used four times a year,” says Mary Kubilus, director of site operations and QA, Celsis Analytical Services, Edison, N.J. While a company may only use this expensive equipment once a month, contract laboratories are using this equipment three to four times a week, which makes them both knowledgeable about the equipment and testing techniques and, therefore, a faster way to market.
Capacity is also an issue that drives companies to outsource. Although many companies would like the development and testing to go through their in house facilities, they may not have the head count to do so. Some companies “may have some testing capabilities, but they may be tied up with quality control work, so they can’t do long term R&D, or some companies are tied down to long term R&D and they can’t do short term problem solving type work,” says Jeff Jansen, Stork Technimet, New Berlin, WI. In many cases it is more cost effective to outsource the product to a contract lab instead of hiring a head count.
Another reason a company might outsource their product is that they wish to have a third party do the testing. “A lot of companies that are instructing their vendors to do environmental stress testing usually want a third party to the testing,” says Terry Candlish, Work Laboratory Manager and Vice President of Operations, CASCADE TEK, Hillsboro, OR. “They want an unbiased party testing the product for integrity and strength, so that what is going to the market is a reliable product.”
Contract laboratories have expertise that includes analytical chemistry, environmental testing, material testing/development, environmental stress testing, and electrical development. Each laboratory has a different focus, receives different tasks, and observes different trends within its industry.
The Inside Scoop on Materials Testing Labs
Following strict and demanding standards is nothing new to material development and testing labs. Depending on the material, the contract services vary and can range from material testing and identification, failure analysis, compatibility and durability testing, and component and systems testing.
When taking a deeper look at metal material, Robinson says, “Many of the metal material products we test follow MIL standard 810, ASTM, AWS and many other customer specific standards which are required for the testing and development of a raw material or product through its projected life cycle.”
To follow this standard, Stork Materials Technology does its testing on specific equipment and methods that are approved by this standard. “Within the MIL 810 standard we use scanning electron microscopes (SEM) for verification of supporting our analysis of failure analysis and fracture mechanics. We also use creep and stress rupture methods to verify the raw materials to make sure they will perform properly.” Although equipment for testing metals range from shock and vibration equipment, environmental chambers, and corrosion testing equipment, Robinson says that SEMs are probably one of the most important pieces of equipment for the engineering and consultancy of metallic materials.
Like with any development process, challenges are expected. Robinson says, “If you have a part of material that is not up to an industry standard, like an ASTM and MIL, when you go to test the material it will fail.” In such as case, contract labs must backtrack to see why the material failed and what can be done to fix this material. To make sure a lab does not face this challenge, materials testing labs must evaluate tensile strength, hardness, and evaluate the grain boundaries and grain structures to ensure integrity.
While Stork Materials Technology has seen an increased demand from industries such as aerospace, telecommunications, and automotive, Robinson claims that “there is definitely a new trend in materials testing focusing on computer technology analyzing of raw materials and their capabilities, which is reducing some of the need for general mechanical chemistry and metallurgical testing of raw materials.”
Robinson has also noted that “there is a new future focus on composite materials and polymers. Metals are being replaced to save energy, weight, and fuel with new polymer composite material.”
With the new turn to polymers, Stork Technimet specializes in the testing and development of plastics and polymeric-based materials. With many contract labs and testing facilities focusing on metallic materials testing, not many know a lot about plastics and polymeric-based materials. Like the testing of metals, the contract services that Stork Technimet offer for polymeric materials vary and encompass a wide range of testing. “We offer material identification of plastics and polymers, quality control work, failure investigation of polymeric-based projects, compatibility and durability testing, and mechanical and physical properties testing,” says Jansen.
However, unlike metals there are more challenges with the testing of plastics and polymeric materials that a contract lab might face. “One of the things that is harder about testing plastics, rather than testing metals, is that there are standardized compositions for metals, but plastics are based upon very large molecules.” While ASTM and MIL standards “call out some very exacting requirements for metals, plastics typically have no ASTM standards as far as compositions,” says Jansen. This makes identifying plastic material harder. Jansen continues, “Identifying anything that goes wrong with the material is a bit harder because plastics don’t have the requirements that give them limits where it would need to be plus or minus this. There aren’t those requirements, so, the very nature of plastic materials makes them different and difficult.”
Because of the “different and difficult” nature of plastics, contract labs that test these types of materials must be equipped with the proper equipment. “Thermal techniques and equipment are important to plastic materials since they have a unique molecular structure,” says Jansen. With thermal analysis equipment, labs are able to focus on plastic’s unique molecular structure in order to ensure integrity and strength.
As far as trends in plastic material testing, Jensen sees that labs have the need to “go smaller.” Labs are now getting more equipment to “be able to increasingly look at the smaller foundations, smaller areas, and smaller sample sizes to be able to make things more micro.” This is especially relevant to polymeric-based materials. “Another trend I see is the need to be more sensitive. This way you could analyze the plastics at a lower concentration and you would be able to make detections of changes within the material,” claims Jansen.
As part of material testing, companies will want to test the reliability of their products before they hit the market or are used within common applications. When a company wants to test the reliability of their product, or material, they will send it to an environmental stress testing lab. With a huge push to test products and parts from the aerospace and automotive industries for reliability, CASCADE TEK, is equipped with the expertise to provide services such as vibration testing, shock testing, temperature cycling, humidity exposure, acceleration testing, and more, to make sure the product is reliable and will stand up to industry standards once implemented in an application.
With a turn around rate of two weeks , CASCADE TEK can ensure the product for market use through their various tests and procedures. The most important and most requested test Candlish sees is vibration testing. “Vibration testing is testing for reliability. Most of the products we receive come from the aerospace and automotive industries where the aircrafts and cars will naturally be exposed to vibrations. So, we will simulate vibrations early to make sure that the company won’t see any issues or touchdown on warranty issues later on,” says Candlish. However, all tests and requirements are dictated to CASCADE TEK before testing is done to ensure the testing meets the specific requirement for the end user.
Candlish explains that “a lot of companies use random vibration in 3 axes” to test their products. For each axis there is “a set amount of time, frequencies and amplitudes for each direction” says Candlish. CASCADE TEK can do vibration testing in 3 axes or 6 directions simultaneously to ensure a product will stand up to the test. If the operation of the sample were to fail during such testing, CASCADE TEK would have to stop the testing and the customer would come to the determination as to why the sample has failed. The customer would then make the appropriate changes and return to the laboratory to either resume the testing from the point of failure or start the testing over if a significant design change was deemed necessary.
Inside Electronic/Software Development Labs
Like materials testing labs, Indesign LLC, Indianapolis, IN, an electronics development and engineering services lab, is no stranger to following strict standards and requirements. Indesign LLC is an “ISO 9001 certified development house. We have detailed design and development processes for each of our design disciplines,” says Jerry Gotway, president and CEO of Indesign LLC. The services Indesign offers range from full product development design, product design engineering, creating prototypes, test engineering services, and more.
Indesign can help any company with any of their electronic and software development needs. Gotway says, “Where we come into the development process varies. We prefer to be involved in the very front end of product development. Many clients that we serve have already done all the product concept work and have developed a detailed set of requirements or specs.” With the requirements and specs already laid out, Indesign will do the detailed design work following the specs.
From medical devices, to mechanical products, to electrical products, all testing gets back to the set of requirements the company provides. With the typical development process starting at requirements, then heading into architecture, then schematics, the PCB layout stage, procuring parts and building PCB assemblies, testing the design, and then releasing their prototype to the factory, Indesign has the proper equipment to aid in the development. Indesign has equipment that ranges from digital scopes and spectrum analyzers to environmental chambers for temperature and humidity testing. Gotway says, “As we go through the design process, and we start building prototypes, we perform validation testing to verify that the prototypes have met all the requirements the company has stipulated.” The testing equipment allows Indesign to meet those requirements and verify the methods used are within the standards.
Because Indesign’s focus is helping companies design and develop electrical, mechanical, and software products, a challenge they sometimes face, according to Gotway, is “that Indesign is designing or developing something that does not exist previously.” And, since they are creating a new product, there is always uncertainty of how each component will come together. “One of the challenges is being able to deal with the unexpected when creating something new,” says Gotway. Despite any unexpected event, the lab must stick to a tight schedule and stay on it. According to Gotway, “we must be able to quickly address any issue that comes up.”
Gotway has observed many trends within the electronics development. “Over the past several years a larger percentage of our new product designs have evolved from wired to wireless designs,” he says. Because users no longer want to be “tethered with a wire” when using their electronic products, Indesign has used many standard wireless protocols in their product designs. Within software, Gotway has seen a lot of Linux being used for embedded software designs. Also within electronics, he has seen new developments in battery technology and a trend to go low power. “Most portable products are often limited based on the available battery life. This has created new developments in battery technology, as well as low power circuit components and circuit design,” says Gotway.
Understanding Good Manufacturing Practices
cGMP (current good manufacturing practices) is a common term heard within the testing and development of pharmaceuticals. All cGMP facilities provide full service compendia testing and validated test methods through the requirements and standards set by the United States Pharmacopeia (USP), Federal Drug Administration (FDA), and the European Pharmacopeia (EP) (along with others), which must be followed rigorously to ensure that there is quality, safety, integrity, purity, and strength built into all testing processes and procedures. “The testing under CGMP is performed using a validated method, whether it is a USP, EP or JP Compendia or developed and validated in-house, so there is no opportunity for the analyst to change the method while testing. What is written down and effective must be followed,” says Kubilus.
As a full service cGMP Laboratory, Celsis Analytical Services takes part in the regulatory approval process when its clients are ready for clinical studies or when they are in need of support as they prepare an application for submission. “We are not involved with the discovery or formulations development end of the time line. Our role begins when the client is are ready for Phase I or II clinical trials to support drug application submissions through test method validation or stability studies,” says Kubilus. Celsis does provide some method development work, although this is not their main focus as a laboratory. This development work is done through the development and validation of analytical test methods stipulated by the company when the product is outsourced.
Following cGMP standards stipulated by the FDA, EMEA, TGA and MHRA is critical in the pharmaceutical industry and can be a time consuming process. The process of sample change of custody requires multiple review tiers within the system. The process that Celsis uses to analyze pharmaceutical samples begins when the samples come into Celsis. “The client will document the product and testing needed onto the contract, and then we, at Celsis, will log it into the sample management system. The sample will then be transferred to the laboratory for testing,” says Kubilus. Once in the laboratory, methods are retrieved. “If the testing is compendia , we at Celsis have the compendia on-line (US and EU) so it is guaranteed that the analyst is using the most recent test method available through the compendia for the product,” says Kubilus. Because the data sheets are also generated online through the validated system, analysts at Celsis are able to readily generate the datasheets specifically for the product being analyzed from the system and start the testing. Once the testing is completed, the results go into Data Review. Once reviewed, the results are entered into the sample management system and a Report of Analysis is generated. The Report of Analysis has two levels of proofing prior to going to quality assurance (QA). The entire data packet with the Report of Analysis enters QA for final QA approval prior to going to the client. Once approved, the client will receive the results of testing, which is used by the client to release the product to market or manufacturing. During the process everything must be documented as by cGMP standards.
Because the term cGMP warrants that quality, safety, integrity, and strength must be built into all procedures, keeping all laboratory equipment calibrated under cGMP standards is very important for Celsis. “The equipment used for analysis is maintained in a calibrated/qualified state as per cGMPs and site SOPs, ensuring any analysis performed by Celsis is the most accurate and highest quality results,” says Kubilus. The equipment in the lab is important because any material that is used in manufacture of product for human or veterinary use as well as the finished product going to market must tested under cGMP as proof of quality, safety, purity, integrity, and strength.
Typical projects for a cGMP lab like Celsis include impurity testing, raw material testing, and stability testing; all of which are important to label claims. Although most of the testing done at the Edison location is raw materials testing, Kubilus applauds the sites stability testing program. “We have over 17,000 ft2 of stability storage between our Edison and St. Louis facilities. The storage units range from cryogenic, which is -70C, up to zone 4, which from the International Conference of Harmonization (ICH) is pretty much the hottest and either the most humid, or least humid, points in the world,” says Kubilus. Celsis’ stability testing program is established through the ICH, and tests for what the clients’ product shelf-life will be in accelerated, intermediate, and controlled room temperatures.
While a pharmaceutical company may take weeks to months to do testing and analysis on a drug, Celsis has a turnaround of about ten business days. “We do have some clients that call us and tell us that they need their testing done yesterday,” says Kubilus. Celsis provides this service as well. “If a client needs to meet a timeline, and requires some testing relatively quick, we do prioritize that service. However, our standard turnaround on a non-rush basis is ten business days,” she says.
As with any type of testing, there are new trends and increased demand within analytical chemistry, which is Celsis’ main focus. One of the new trends observed by Kubilus is the need to check for melamine in products. With the scares the U.S. has had with melamine coming out of China in baby food, as well as pet food, the FDA “is warranting that the industry is now required to test certain raw materials coming into the country from China for melamine,” says Kubilus. With this requirement, Celsis is currently working on HPLC methods, as well as LC/MS methods to analyze for this poison in any sample that may cross through their doors. “We have already been receiving calls from our clients regarding this. This will open up more doors for the melamine initiative,” says Kubilus.
