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Rapid and reliable identification and validation of incoming raw materials is critical for drug manufacturing Full-time Job

Mar 31st, 2022 at 07:55   Security & Safety   Babadag   51 views
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manufacturing

Impurities and adulterants in raw materials pose potential health threats when present in the manufacturing of pharmaceutical APIs and drug products. These same impurities and adulterants may also result in lower production yields and greater needs for product purification. Thus, their identification and quantification within incoming raw material play an important role in the pharma industry, ensuring product safety & quality, and an overall smooth and cost-efficient manufacturing process.

Bruker offers a complete portfolio of analytical systems for quick and accurate identification of raw materials.

X-ray fluorescence (XRF) is a reliable, precise, and accurate technique with the potential to analyze inorganic impurities at ppm or even sub-ppm level in many types of raw materials used in the pharma industry. XRF is also ideal for quick identification of certain substances, such as the differentiation of KCl and NaCl. Modern high-end laboratory energy-dispersive XRF spectrometers allow for high throughput, are easy to operate, and comply with applicable data management regulations (e.g. 21 CFR Part 11). Portable XRF units can be used for a quick assessment of a new delivery upon arrival.

Key advantages of XRF compared to more classical wet chemical techniques are the fast and simple sample preparation, the ease-of-use, and the low operation costs (no toxic/expensive chemicals/gases required!

Uniquely, XRD directly probes the atomic and molecular arrangements in solid forms. X-ray powder diffraction, therefore, enables detection, identification, and quantification of crystalline and amorphous APIs, excipients, and other any materials via fingerprinting. Raw materials can be quickly screened to control purity, crystallinity, and polymorphism as well as absolute phase abundance in mixtures.

FT-NIR spectroscopy via fiber optic probes is rapidly becoming a standard method of accomplishing this crucial material validation, providing unprecedented speed and flexibility for the identification of both solid materials and liquids.

Both MPA II and MATRIX-F FT-NIR spectrometers can be equipped with fiber optic probes for direct analysis of raw materials in their containers. Complete identification software guides the user through the library creation process and provides single-click identification even at the loading dock. The MATRIX-F system comes with a NEMA rated enclosure enabling it to withstand the toughest plant environments.

Incoming goods inspection and quality control using FT-IR spectroscopy are mainly performed using the so-called ATR (Attenuated Total Reflection) technique. It allows measuring IR spectra of almost all types of liquid, solid, and paste-like samples within some seconds. For identity control, the sample spectrum is compared against the spectrum of a reference substance.

The growing demand for portable Raman systems for material verification is constituted in the vast capabilities of this spectroscopic technique. High selective information content and no need for sample preparation combined with the capability to probe materials directly through transparent packaging material often make Raman spectroscopy as the method of choice.

Bruker developed the BRAVO to overcome the limitations of handheld Raman spectroscopy like fluorescence or safety issues. As a class 1M laser product, BRAVO combines maximum user safety with the utmost ease of use, of course fully compliant to regulations like CFR 21 Part 11. BRAVO is the lab in your hands for material verification in the pharmaceutical industry.

NMR on the other hand, being a structural rich technique and inherently quantitative, offers the advantage of testing the identity of raw materials and their quantification in the same experiment, which can take less than 1 minute. Should impurities be detected, NMR and MS are the techniques of choice to elucidate the unknows, providing go- or no-go information.

The Benefits of Plant Extracts for Human Health

Nature has always been, and still is, a source of foods and ingredients that are beneficial to human health. Nowadays, plant extracts are increasingly becoming important additives in the food industry due to their content in bioactive compounds such as polyphenols and carotenoids, which have antimicrobial and antioxidant activity, especially against low-density lipoprotein (LDL) and deoxyribonucleic acid (DNA) oxidative changes. The aforementioned compounds also delay the development of off-flavors and improve the shelf life and color stability of food products. Due to their natural origin, they are excellent candidates to replace synthetic compounds, which are generally considered to have toxicological and carcinogenic effects. The efficient extraction of these compounds from their natural sources and the determination of their activity in commercialized products have been great challenges for researchers and food chain contributors to develop products with positive effects on human health. The objective of this Special Issue is to highlight the existing evidence regarding the various potential benefits of the consumption of plant extracts and plant extract-based products, along with essential oils that are derived from plants also and emphasize in vivo works and epidemiological studies, application of plant extracts to improve shelf-life, the nutritional and health-related properties of foods, and the extraction techniques that can be used to obtain bioactive compounds from plant extracts.

In this context, Concha-Meyer et al. studied the bioactive compounds of tomato pomace obtained by ultrasound assisted extraction. In this review, it was presented that the functional extract obtained by ultrasounds had antithrombotic properties, such as platelet anti-aggregant activity compared with commercial cardioprotective products. Turrini et al. introduced bud-derivatives from eight different plant species as a new category of botanicals containing polyphenols and studied how different extraction processes can affect their composition. Woody vine plants from Kadsura spp. belonging to the Schisandraceae family produce edible red fruits that are rich in nutrients and antioxidant compounds such as flavonoids. Extracts from these plants had antioxidant properties and had shown also key enzyme inhibitions. Hence, fruit parts other than the edible mesocarp could be utilized for future food applications using Kadsura spp. rather than these being wasted. Saji et al. studied the possible use of rice bran, a by-product generated during the rice milling process, normally used in animal feed or discarded due to its rancidity, for its phenolic content. It was proved that rice bran phenolic extracts via their metal chelating properties and free radical scavenging activity, target pathways of oxidative stress and inflammation resulting in the alleviation of vascular inflammatory mediators. Villedieu-Percheron et al. evaluated three natural diterpenes compounds extracted and isolated from Andrographis paniculata medicinal herb as possible inhibitors of NFκB (nuclear factor kappa-light-chain-enhancer of activated B cells) transcriptional activity of pure analogues. Yeon et al. evaluated the antioxidant activity, the angiotensin I-converting enzyme (ACE) inhibition effect, and the α-amylase and α-glucosidase inhibition activities of hot pepper water extracts both before and after their fermentation. These water extracts were proved to have potentially inhibitory effects against both hyperglycemia and hypertension. The hydrolyzed extracts of Ziziphus jujube fruit, commonly called jujube, were examined for their protective effect against lung inflammation in mice.

Fine chemicals: Membrane technology in the fine chemicals industry

Fine chemicals are chemicals produced in small-to-medium quantities but their definition is imprecise and wide ranging, including pharmaceuticals. Here we concentrate on agrichemicals, specialist chemicals and high purity chemicals typically synthesised in small batches for producing products such as dyes, pigments, coatings, flavors, fragrances, lubricants and microelectronic grade chemicals.

In an issue of Filtration+Separation, published in July/August 2008, Ken Sutherland outlined the range of products produced in the chemicals industry. He focused on bulk chemicals but gave a useful summary of the chemicals industry as a whole, including pharmaceuticals and biotechnical products. This represented the largest sector of the membrane market in 2007, with 30.6% of the global total. The fine chemicals sector represents around a quarter of the whole membranes chemical market. This smaller sector is characterised by a range of diverse applications for membrane technology, covering three main aspects:

• production of process water, subsequently utilised in the manufacturing process or in the dilution of fine chemicals;

• filtration and separation of the fine chemicals themselves; and

• treatment of effluent from fine chemicals production processes.

Fine chemicals are pure, single substances that are typically produced by chemical reactions for highly specialised applications. The fine chemicals produced can be categorised into active pharmaceutical ingredients and their intermediates, agrichemicals, speciality chemicals and high-purity chemicals for technical applications.

In contrast to bulk chemicals, which are produced in massive quantities by standardised reactions for subsequent direct use, fine chemicals are custom-produced in smaller quantities for special uses. The methods of production need to be flexible, and owing to the relatively small volumes required and the diversity of types, the definition of fine chemicals is wide ranging. Production is more expensive than for bulk chemicals, generates more effluent that can be difficult to treat, and requires a higher research investment per unit weight produced. Fine chemicals are, however, produced in industrial quantities unlike research chemicals, but batch production tends to be common as opposed to continuous production for bulk chemicals.

Company Description
Rapid and reliable identification and validation of incoming raw materials is critical for drug manufacturing