Chemical and pharmaceutical wastewaters are among the most difficult to treat biologically. Typically high-strength, and containing components that are potentially toxic or inhibitory to biological activity, such wastewaters require a specialized knowledge in treatment plant design. ADI Systems has decades of experience treating chemical and pharmaceutical wastewaters for some of the world’s largest companies, and our hard-earned experience and continuous research have kept us at the forefront in this field. By their very nature, these wastewaters present unique challenges. A cookie-cutter approach to technology selection and system design is not appropriate. By conducting detailed treatability studies of the wastewater, and carrying out pilot studies, if necessary, we tailor each system to meet the client’s particular needs. We can offer a variety of technologies, adapted as necessary to achieve the most efficient, reliable treatment possible. Due to the typical high strength of these wastewaters, this can result in major reductions in sewer charges and generate significant quantities of energy-rich biogas. Unlike many industries, the processes within the Chemical and Pharmaceutical industries are many and varied, often designed to meet the needs of a particular product. Careful selection and specification is vital to ensure the most appropriate solution to meet unique sealing requirements. Increased reliability is achieved on high solids applications with the Type 2800EX cartridge seal, 670, 680 and GL1B metal bellows or 5860 cartridge seals. Heat Transfer Services present very predictable applications with extreme product performance requirements. The John Crane Type 609 metal bellows with grafoil or Type 2609 dual metal bellows & grafoil cartridge seals were developed for a broad range of heat transfer duties. Polymerisation is a common source for rotating equipment failure. Heat sensitive products or fluids, which solidify in the presence of cooling liquid, have shown dramatic increases in MTBR (Mean Time Between Repair) and uptime with the Type 2800 Series. The absence of frictional heat and cooling/flush liquids eliminates the cause of polymerisation. Challenging and unique applications such as high pressure, high speed, Polymerising fluids, HF alkylation and aggressive acids, high temperature fluids and de-watering applications require experience and proven customised designs. By eliminating liquid based support systems the Type 2800/E ensures 100% product purity, provides non-contacting, dry running capabilities on transfer services and therefore dramatically reduces operating and maintenance costs. The modular design of the John Crane 5600 family of cartridge seals provides optimum flexibility and reduced inventory. This design allows changes from single to double, from pusher to metal bellows, from pressurised to non-pressurised all within the same cartridge. WHY DO WE USE THE WORD PHARMACEUTICAL? For more than 35 years Biotics Research has been a primary manufacturer of leading edge dietary supplements. Every product is manufactured in our fully licensed, FDA approved pharmaceutical and CDC licensed genetics and toxicology testing laboratory. Biotics is licensed by the United States Center for Disease Control and the FDA as both a manufacturer and distributor of pharmaceuticals. As such all products have an NDC (National Drug Code) number and are listed in the FDA Drug Registration and Listing database- a level of quality control that is above and beyond that required by third party issuers of GMP certificates. QUALITY CONTROL Biotics Research is fully licensed by the FDA to manufacture pharmaceuticals, as such the level of quality control, raw material testing, chemical laboratories, and manufacturing operating procedures are far superior to just a licensed food manufacture which are better known as makers of dietary supplements . No other dietary supplement company in the industry can make this claim. Commonly, dietary supplement companies use terms like “GMP (good manufacturing policy’s) certified” to promote the quality of their products. The truth of the matter is, the only GMPs that count are those implemented by the government and no independent issuer of “GMP certificates” meet the proposed federal US FDS GMP standards for dietary supplements, nor does the FDA recognize these independent certifications. Lastly, the manufacturing that Biotics Research practices, far exceeds those of the so called ‘independent certification’ practices and more closely resemble those of drug GMPs mandated by federal and state agencies. Features of an ‘In-House’ manufacture As a primary manufacture of pharmaceuticals and dietary supplements, all products are made in the Biotics Research laboratory- including capsules, tablets, liquids and powders. Thus Biotics has control of the ENTIRE manufacturing process from start to finish. All products, including gel capsules, are tested for contaminants, peroxide levels, and heavy metals. Botanicals are identified via their biological identity through the photochemical laboratory. Why is this important? Companies that out-source their manufacturing purchase products made by contract manufacturers, who bid against each-other to get the deal. Quality is compromised to keep the cost low so that the manufacturer will get the bid. As a primary manufacture, the selection of raw materials is based on quality, not cost. PRODUCT SAFETY: The use of harsh chemical solvents such as chloroform, hexane is common practice in the material processing of dietary supplements. Biotics Research uses natural organic acids commonly found in the body when processing raw materials. Excipient binders and fillers are commonly using in the pharmaceutical and dietary supplement industry, often times comprising up to 40% of the finished product. This is typically listed as “other ingredients” and includes unhealthy compounds like titanium dioxide, microcrystalline cellulose, stearic acid, silicon dioxide, calcium silicate, hydrogenated soybean oil encapsulate, croscarmellose sodium, maltodextrin, hypromellose, polyethylene glycol and carrageenan. At Biotics Research the tableting base is a ‘vegetable culture’ made of dehydrated vegetable material which dissolves readily and is rich in phytochemicals. Biotics does use some natural excpients that are required for processing such as vegetable source stearic acid and magnesium stearate. Product Disintegration: Biotics routinely performs dissolution tests on tablets and capsules to ensure the product will disintegrate within a specific period of time and for adequate absorption and utilization in the body. Manufacturing Equipment: The scientists at Biotics Research are some of the most highly skilled in the industry. The have equipment that test for product and ingredient identity, potency, biological activity, microbiolological and chemical contaminants and stability. They routinely employ methods such as HPLC, ICP, TLC, IR and FT-IR, gel electrophoresis, and UV spec among others. As part of the GMPs at Biotics Research, they tests all incoming raw materials, in-process products, finished products, and performs testing to validate processes and ensures that at the time of the expiration date all ingredients are active and efficacious. NIR chemical imaging is based on the same principles as NIR spectroscopy, but uses a focal plane array detector in place of a single detector element to capture the spectral signature at tens of thousands of spatially resolved positions simultaneously. Some have called it NIR spectroscopy on steroids! The parallel data acquisition results in a very high throughput; one image takes under 3 minutes to acquire, which corresponds to 2 milliseconds per full spectrum. For certain quality control applications, such as monitoring the spatial distribution of an API for example, it is possible to acquire the spectral information at a few selected wavelengths. In the latter case, all spatial positions are interrogated in a few seconds, which means that hundreds to thousands of discrete samples can be imaged in a day. The main difference between NIR chemical imaging and traditional NIR spectroscopy is the dimensionality of the measurement, which relates to the purpose of the measurement. Traditional NIR spectroscopy is an averaging technique; a single spectrum is acquired from a fairly large spot and possibly all the way through a tablet. This spectrum represents the average chemical composition of the tablet and is very powerful to determine the concentrations of various organic ingredients. NIR chemical imaging is a detail-oriented technique; a multitude of spectra are acquired, each from a very small spot on the tablet and from a limited depth. Each spectrum represents the chemical composition of a small area, which enables the comparison of all the spots acquired to determine the spatial distribution of various ingredients within one tablet. This spatial distribution is then compared amongst samples and correlated with performance parameters such as dissolution rate and stability. When should it be used? NIR chemical imaging is a very powerful tool for the analysis of coated and uncoated pharmaceutical tablets, granules, extrusion cores and transdermal delivery systems. The key is always to aim for an application where it is the chemical heterogeneity present within the sample that is important. Chemical heterogeneity can be deliberate and part of the structure that yields the desired performance, or it may be caused by process changes and negatively impact performance. Such applications abound in various steps of formulation design, analytical services and quality control. Examples include the determination of blending, coating or milling endpoints in formulation design, risk assessment of ingredient selection and changes of suppliers, troubleshooting of dissolution failure, and counterfeit detection and sourcing. If the analysis seeks a comparison of means (for example dose uniformity between tablets), traditional NIR spectroscopy is more appropriate. Most analyses performed with NIR chemical imaging on solid dosage forms are done in diffuse reflectance — a sampling technique that simply involves positioning a tablet or other sample on the sample stage and "staring" at it with the camera for a few seconds to a couple of minutes. The main advantage of using diffuse reflectance in NIR imaging with a system providing a wide depth of field is the absence of sample preparation, which increases analysis speed and decreases personnel involvement (and associated cost). Finally, NIR chemical imaging is a great tool for Quality by Design (QbD), laboratory analysis and even at-line measurements, but generally overkill for on-line monitoring. The technology exists to perform blend monitoring on line and automation in data analysis can be implemented, but experience has revealed that it generates an amount of data that often needs to be distilled down to become manageable, to a point that makes it only marginally more informative than a single point, traditional NIR on-line probe would have been. The cost of on-line implementation is also an important consideration. Also, NIR chemical imaging is better suited for solid samples; powders with a particle size in the single or tens of microns range are better interrogated by a particle imaging system. Such systems can rapidly sort through tens of thousands of particles to find the ones of interest based on size and shape; chemical analysis with a spectroscopic approach can then be more efficiently performed strictly for these selected particles. How does the industry benefit? Better understanding of processes and products leads to better control, a smaller regulatory burden when the time comes to implement changes and better profitability. In this regard, NIR chemical imaging is fully aligned with the QbD initiative and provides information that bridges the gap between starting material quality assurance and performance verification of finished tablets, transdermal patches and oral wafers. In addition, the ability to analyse intermediates enables the gathering of a knowledge base on the effects of ingredients and modifications at various stages of the process during formulation development, and further link into the consequences for finished products. In short, NIR chemical imaging is a risk assessment tool that provides quantitative data for the determination of critical quality attributes. The knowledge gathered during formulation development can save a lot of time and money when having to deal with a performance failure. However, even when it is not used to collect this important information during formulation development, NIR chemical imaging remains a powerful tool for root-cause analysis of performance failure of finished products and intermediates, enabling the rapid implementation of corrective measures. As such, it can have a significant impact on production efficiency and cost. The power and limitations of NIR chemical imaging are quite well-understood at this point and the technology already available will satisfy measurement needs. We believe that NIR chemical imaging-derived information will be increasingly requested for new product applications because of the fact that it bridges a gap in product and process understanding that is important for the success of QbD. As more applications include the technical data acquired with this instrumentation, there will be less acceptance of the old gaps in knowledge and assumptions. The future Automation of both data acquisition and processing will definitely see the most innovations over the next decade as the technique moves into routine measurements for formulation development and quality assurance. It will become more of a "walk-up" instrument, utilised by non-spectroscopists and providing a numerical, or even a pass/fail type of answer. Standard operating procedures and validated methods will be key to routine deployment, especially to address the needs of ever-shrinking analytical laboratory staff in many pharmaceutical companies.
Posted on: Wed, 04 Sep 2013 10:43:53 +0000
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