Contract Mfg. Roundtable Part 4

The main page for the entire Q&A discussion can be found here.

Contract Manufacturing Q&A Part 4

Are you seeing greater interest in functional foods/beverages, and do you offer production and/or formulation assistance in those areas?

Provenzano: Were somewhat seeing more interest in functional foods and beverages. If a customer approaches us about making one of these products, they tend to ask us to manufacture it in powder form. Powders are more attractive because of the low minimum requirement and low cost associated with them. Also, as it relates to convenience, consumers tend to like products in powder form because they can mix it with water or another liquid and take it on the go with them.

Ishaq: Yes, foods and beverages is a viable and growing market; in 2008, we expanded our liquid manufacturing operation to make functional beverages and liquid supplements to our clients.

Dockery: There has definitely been an increase in interest in alternative dosing forms for nutritional products, including functional foods and beverages, as well as convenience packaging. People are more mobile now than ever before and as a result, there is an increased interest in products that are portable and easy to carry around. National Enzyme Company has recognized this trend and has expanded our packaging options beyond bottled capsules. We now offer assistance in formulating supplements in a wide variety of administration forms.

Sysler: The interest in functional foods and beverages continues. We provide more in the area of ingredients for this category that manufacturing of finished products. However, the ready to drink product is very strong and many companies are looking to develop products in that category that include the functional ingredient. We can provide both formulation ideas and manufacturing of finished products.

Koon: Yes. We make a number of powder functional beverage-type of products. Protein, meal-replacement, fibers, etc.

Paternoster: In the powdered drink mix product category, we are experiencing growth in this area. For example greens, healthy meal replacements, energy drinks, probiotics, and fiber products.

Majeed: Since Sabinsa carries a number of functional foods/beverage ingredients, its natural, no pun intended, for customers to ask about our offerings in certain types of formulations. While we cannot make any food type of products here, Im talking muffins, cookies or beverages, we can help deliver the blend of ingredients they can use at another facility. For example, we have a line of ingredients that are completely water soluble, some with GRAS self-affirmation, where the functional aspect of the ingredient can come alive.

What capabilities do you have that assist companies looking to expand their sales into international markets?

Ishaq: Due to our ample experience in export documentation such as free sale, export, manufacturing and distribution certificate, country of origin, we manufacture product and provide our customers services to export their products globally to expand their businesses.

Lu: We have a great deal to offer. Our standard certifications that are recognized internationally include TGA, NSF, NSF Sport and Star K. We have experience in over 37 countries worldwide, and a multi-language assistant (including Spanish, Portuguese, Chinese and Taiwanese). We offer formulation and product development expertise that can customize products based on different cultures and diets. NEC is also familiar with the U.S. government's programs for export assistance.

Kaufman: International distribution requires a lot in the way of additional documentation, Our technical staff has a lot of experience in the documentation and testing requirements.

Allison: We have experience in the exportation of products to many different countries. We can provide the necessary information needed to get products registered. We have worked with freight forwarders and understand their documentation needed to get product on the water.

Sysler: We assist companies with international sales by providing required documentation and wherever possible, providing insight into material requirements and regulations for that country.

Koon: We are quite experienced in international sales. We already sell and import directly to and from the international marketplace. We currently sell to Asia (China, Taiwan, Japan, Hong Kong, Korea, Malaysia, Indonesia, etc.), the Middle East (Dubai), Europe, Canada and South America.

Akand: We have been exporting products to the Middle East for nearly a decade. In fact, we have a regional sales office in Dubai to deal with the specific requirements of the international regulatory agencies of the respective country in the Gulf Cooperation Council states. Although the recent recession has negatively affected the region, we expect increased growth there in the next ten years.

Falkenstein: UAS works with companies in 37 different countries and we are very familiar with requirements in each of those companies.

Paternoster: We have experience manufacturing bulk and packaged products that are exported to most countries. The primary benefit of working with NSP for exporting products is our ability to create detailed product dossiers (master files) with the product chemistry and testing required by most countries outside the United States, for preapprovals and licensing.

Majeed: Sabinsa built the Utah manufacturing facility targeted for international business, and so with our offices in over six other countries, we receive numerous requests for formulation, regulatory and other services from many domestic companies looking to go overseas. We have certain grades of our material that are made specifically for, as an example, the Japanese market, and we can help formulate here in the United States into caps/tabs and/or supply in bulk the raw material required to make the final product in their country of choice.

How extensive is your in-house laboratory testing operation? To what degree do you make use of third-party laboratories?

Provenzano: All of our testing is done in-house. We double check all raw materials in our warehouse or are given to us. We conduct micro and identity testing of products and provide a certificate of analysis once testing has been completed. We also ask any customer that provides us with raw materials to provide us with a certificate of analysis (C of A) prior to us testing them. From there well also conduct our own testing to confirm that the raw materials have not been contaminated in any way during shipment.

Ishaq: We have a fully capable in-house testing lab. We perform identification of all incoming raw materials through FTNIR. Assay analysis is carried out by High Performance Liquid Chromatography (HPLC). We have a separate microbiology lab where we perform standard microbes and pathogens testing. We have increased the number of lab equipment such as viscosity, pH, conductivity, TDS and resistivity meters to perform all of our testing in-house. Our fully automated production lines are now equipped with metal detectors, automatic labeling machines and shrink sleeve tunnels. Our liquid manufacturing lines are equipped with high speed mixers, filling machine, metal detectors and heat induction sealers. We monitor and perform thorough water quality analysis as well.

Cairo: We have in-house testing capabilities at most plants, but usually will use a third-party lab for compliance testing to meet contract guarantees.

Paydon: National Enzyme Company maintains ownership of SORA Laboratories LLC, which operates as an independent contract testing facility. The capabilities of SORA Labs include analytical, physical, and microbiological testing. SORA Labs is equipped with state-of-the-art instrumentation, including GC MS, HPLC DAD, UPLC, ICP OES and FT IR and will be ISO Certified/Accredited by the first of the year. These analytical instruments, in combination with the highly-skilled staff of degreed chemists and microbiologists who operate them, ensure the quality and safety of NEC's products from concept to shelf. Third-party laboratories are used on occasion where specialized equipment is required, or for purposes of independent verification of in-house testing results.

Holtby: We have a variety of high-tech laboratory equipment that we use to help our operation. Our lab contains two gas chromatography (GC) machines, four HPLCs, one atomic absorption, one UV spec and one FTIR. Most are used for potency testing, although the FTIR is mainly used for identification. Some specialty testing is handled by outsourcing.

Kaufman: We have a full service laboratory, that includes accelerated shelf-life stability; flame atomic absorption; Disintegration, dissolution, friability testing; fill-weight, hardness and thickness; fluorescent spectrophotometry; FTIR; HPLC; graphite furnace atomic absorption; microbiological testing; microscopic image analysis; ORAC; particle size distribution analysis; thin layer chromatography (TLC); ultraviolet-visible (UV-VIS) spectrophotometry; and HPTLC.

Archer: We test every barrel every time. We test for all banned substances on the World Anti-Doping Code. We test for all metals on the periodic chart of elements. We use third parties only when we are sending for additional verification.

Allison: We have expanded greatly in our compliance process. We still send product out to third parties for microbiological and other complex testing.

Sysler: Our in-house lab testing has grown significantly with the adherence to GMPs. We now have eight people in QC and do most of the testing in house. Our equipment includes LC/MS, GC/MS, ICP/MS, HPLC, TOC, IR. AA and others. We do full micro testing (full plate counts, yeast and mold), challenge tests, stability and others. When requested by customers, we send material out to qualified third party labs. We also use outside labs for certain testing not done by us such as ORAC value and pesticide tests. Ultimately, we expect to expand our testing to include some of these other areas. This gives us an edge by providing onsite testing and quicker turn around times.

Koon: We use our own in-house labs, in addition to using outside labs for our testing. All microbial testing is done in-house. Our current laboratory testing equipment list is: HPLC (two), GC, TLC, FTIR and ICPin addition to rest of standard laboratory equipment.

Akand: We have developed several international standards and methodologies for the ingredients and products we process. In fact, we have a patent-pending methodology for quantitative and qualitative testing of tryptophan. However, given the sheer volume of ingredients, sometimes we need to outsource our laboratory testing to third-parties. Similar to our raw material sourcing requirements, our third-party laboratories are also subject to physical audits by our technical affairs team.

Paternoster: We have a complete analytical testing laboratory, staffed with personnel who have graduate degrees, training, and decades of experience as chemists. A recent growth area has been in our Prop 65 testing and development of products designed to meet Prop 65 Safe Harbor Levels.

Majeed: Our in-house laboratory takes care of 100 percent of the items we work with. With our recent certification and future ones were looking too, they are advising at least two to three times per year we look for third-party laboratories for validation purposes. We believe in this and will follow it closely.