2020/06/30

GMP Qualifications And Validations In The Pharmaceutical World

Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. Good manufacturing practice guidelines provide guidance for manufacturing, testing, and quality assurance to ensure that a food or drug product is safe for human consumption. Many countries have legislated that food and pharmaceutical and medical device manufacturers follow GMP procedures and create their own GMP guidelines that correspond with their legislation.

2020/06/30

Where Tableting Technology Is Heading

The tablet making industry is currently going through a period of significant change. An increasing number of patents are expiring giving tool makers and tablet manufacturers plenty of opportunity to innovate in a range of technologies. There is also an increase in the number of manufacturers of generic products and specialists under contract to the large established pharmaceutical companies. Another dynamic force in the business environment is the increase in competition brought about by the opening of markets in developing countries and companies that are relocating their facilities and operations to take advantage of these opportunities. Consequently there is pressure on tablet manufacturers to provide their clients, both the established pharmaceutical companies, specialist contractors and those who manufacture generic tablets, with equipment that increases production volume and at the same time lowers operating costs. The need for standards In 1966 Engineer Swarz (employed by the then Smith Kline French company—presently known as Glaxo Smith Kline) acknowledged that there was a need for international standards for tablet compression tooling in the pharmaceutical industry. At that time he saw a need to develop a compression tool that could be sourced from providers other than the original equipment manufacturer (OEM). At that time, the lead time for purchasing new tooling could exceed 6 months, which significantly extended the time necessary to introduce new products onto the market. The standardization of the tooling that was envisaged in the 1960s and developed in subsequent years has enabled manufacturers to source tooling equipment for various tablet presses in a much shorter time frame. The American Pharmaceutical Association supported the introduction of standards for tablet making by publishing their standard guideline manual (the IPT manual). The publication, known today as the Tableting Specification Manual or the TSM Standard, is currently in its 7th edition. The manual continues to be one of the leading resources for helping tablet press and tooling manufacturers to specify tablet compression tooling equipment. After the release of the third edition of the TSM, a British company – I Holland Ltd. realized the need for a European equivalent of the TSM guideline the European community. This led to the introduction of the I Holland Eurostandard which is now the most comprehensive guide available for the standardisation of tablet punches and dies. It is used worldwide for European-built tablet presses. The 2010 edition has been modified to be compatible with the ISO 18084:2005(E) standard. Unfortunately there are shortcomings with current standards. For example, these fail to address the position of the upper punch key, which is required for shaped tablets such as ovals. The lack of a specification in this instance means that manufacturers can build presses with the key in different positions. This prevents the possibility of interchanging the tooling for common presses. For example, two different manufactures may fabricate the same tooling equipment and follow the “B” format standard assuming they will be interchangeable. The problem is manifest during the ejection cycle of the tablet making process, if the tooling is not interchangeable the punch may not be properly align with the die and consequently the tablets may need to rotate or spin during ejection. This can cause the tablets to accumulate on the die table, leading to damaged tablets and reduced the output. The random keyway could result in high operation costs as many tablet manufacturers may be unaware of the problem. Additional costs may be incurred to overcome the problem by purchasing additional sets of the same tooling equipment. This example clearly shows that there is still work to be done on developing universal standards and the industry, including the tooling vendors and users should support the update to ISO 18084 and help complete the standardization for the key type and location.Innovation drivers Ever increasing production costs and addressing issues such as the keyway problem are examples of what drives innovation in the industry. Such issues also spur refinement and internal organization of the complete manufacturing process. The capital tied up in the machinery asset base is just one cost element for pharmaceutical companies. Equipment efficiency, waste reduction, time to market and the inventory cost of assets should also be taken into consideration as potential areas where innovation could make a big difference. Another specific example of innovation in tablet making machinery is the Continuous Weight Control System, which allows a tablet to be checked for weight at least once in every turret revolution. As all the stations are checked at the same time, it permits continuous checking of the tablets and ensures that precise weight data is collected and stored for the equipment, thus ensuring that quality is m

2020/06/30

Belt Dryer Common Faults And Maintenance During Use

Although the belt dryer is relatively energy efficient dryer, but in practice there is a failure, and we have done is to identify the cause of the fault to be eliminated, so that belt dryer best energy efficiency for us service. So when customers buy a belt dryer, pay attention to the configuration of the dryer, the selection filter on the belt dryer to the dryer tooth channel and the aperture adapted, generally selected mesh filter diameter is dried machine into the channel or aperture to 0.2 times. ??? Belt dryer is in use common fault which how to resolve how to do maintenance to tell you about a few: 1, before starting to deal with triple gas source to check the water in the discharge and to ensure adequate oil level. 2. Make sure the dryer has a good grounding device, temperature meter on the device should be subject to verification. 3, parts inspection and maintenance, such as lubricating the bearing, adjust the pulley, check the electrical wiring, door rocker, pipe joints and so on and fixed. 4, raw fire fault may be drying machine equipment design, material or go suck not cause a fire inside the dryer and the like. In addition, there may be caused by human factors, such as to achieve the drying effect of the force is too small dryer heating caused by fire. In this case the transformation is best to replace the dryer equipment, check the dryer is installed correctly, leaks or increase the pressure and the like. The proper use of the dryer, the dryer cautiously increasing temperature, so as not to cause a fire. 5, appear raw disposable baking quit problem, which is mainly due to the dryer is too small or cause improper use of dryer and other reasons. In addition, wind network pressure, flow calculation is wrong also cause such a failure. You can replace or re-modify the drying equipment, or require manufacturers to recalculate pressure, flow and other changes to the program. If it is due to improper operation, the operator in strict accordance with the instructions for proper operation. 6, to ensure that no loose bolts fixed base, support spring elastic fit connection, computer control panels, wind turbines, heat exchangers, with good flexibility. 7, to keep equipment clean, wipe the equipment daily, to clean up the dust tank fluff to ensure ventilation. After regularly clean the inside of the lid opening device.

2020/06/30

Belt dryer scope of application and selection

Use of belt dryer is very wide, present in the pharmaceutical, food, biological, chemical and other fields already have it handy. However, in each area of its selection criteria is not the same, because the requirements and parameters of the dried material in various fields have a greater difference. For example: in the pharmaceutical industry (especially medicine), extract viscosity are generally large, and drying temperature requirements more stringent, the melting point of control to be precise (especially polysaccharide material), the control range to meet the different degree of vacuum heating and temperature requirements of section to have online auto tuning function, and so on. Also to try to improve the detection system to comply with pharmaceutical GMP standards. The first step in selecting a vacuum belt dryer is the need for drying materials for sample test, which is very important. So for equipment suppliers whether it has a material testing equipment and experienced personnel sample is the most direct way to measure customer the manufacturer's capabilities. Qualified vacuum belt dryer manufacturer usually after the test material can in the shortest possible time to provide customers a comprising: actual evaporation material, dynamic drying vacuum, drying temperature distribution, mass size, actual drying time actual product specifications report production, energy consumption per unit of consumption ratio, enabling customers to choose according to requirements to meet production equipment models and specifications. Select vacuum belt dryer of the second step is a comprehensive study level of the manufacturer's design and manufacturing capabilities. In general, manufacturers will be on the basis of material to provide a test report on the preliminary technical design and program design detailed statement of reasons in accordance with the customer's production targets and working conditions. Technical design is assessed manufacturers manufacturing capacity vacuum belt dryer extremely important part, especially manufacturers of key technology and equipment design as described: design design vacuum system, heating system, correction system design, cleaning and feeding system design, system design and other materials. Another aspect of the manufacturing capacity is to examine the manufacturer's user's actual usage. Customers can according to the manufacturer's user list, requirements to the site visit, if the manufacturer does not generally have sufficient strength to reject the reasonable demands of customers, and some even provide targets for customers to choose more than one visit. And limited manufacturing capacity or a lower level of technology companies generally difficult to do this. The third step is to select a vacuum belt dryer is to investigate the actual processing capacity and production scale manufacturers. The vacuum belt dryer due to the large volume, auxiliary equipment and more high configuration requirements, the middle part of the complex, etc., to keep the equipment running for a long time to stabilize and easy.The price of this device is also more expensive, users are generally optimistic about its drying capacity and technical advantages of the use of huge amounts of money while purchasing, so are hoping to recover the cost as soon as possible to improve the economic efficiency of enterprises. Therefore, in the procurement of equipment be sure to choose the size, design and manufacture of practical experience and reliable service with the manufacturer to ensure that the system can be assured, of course, this provided by the manufacturer of vacuum belt dryer is generally slightly higher price point, but for users, the use of a sense of security, customers must not covet a moment because of low price and may affect the overall situation.

2020/06/30

Spray Drying In The Pharmaceutical Industry

Spray drying is one of the most remarkable technologies currently to be applied to pharmaceuticals. It is a continuous process that converts, in a single step,  a liquid feed into a powder and is an ideal process when precise attributes such as particle size, morphology and stability are required. This review describes  the technology, current and future applications and how the present level of understanding and modeling tools enable a process development stage that is  both lean and risk-free.

2020/06/30

Difference between dry granulation and wet granulation-victor granulator?

Wet Granulation: The process of adding a liquid solution to powders involves the massing of a mix of dry primary powder particles using a granulating fluid. The fluid contains a solvent that must be volatile, so that it can be removed by drying, and be non-toxic. Typical liquids include water, ethanol and isopropanol, either alone or in combination. The liquid solution can be either aqueous-based (safer) or solvent-based. Water mixed into the powders can form bonds between powder particles that are strong enough to lock them together. However, once the water dries, the powders may fall apart. Therefore, water may not be strong enough to create and hold a bond. In such instances, a liquid solution that includes a binder is required. Once the solvent/water has been dried and the powders have formed a more densely held mass, then the granulation is milled. The process can be very simple or very complex depending on the characteristics of the powders and the available equipment. In the traditional wet granulation method, the wet mass is forced through a sieve to produce wet granules that are subsequently dried. A subsequent screening stage breaks agglomerates of granules. Organic solvents are used when water-sensitive drugs are processed, as an alternative to dry granulation, or when a rapid drying time is required. Because direct compressing is not the best technology for many active substances, wet granulation is still a preferred method. Even if the active substance is sensitive to hydrolysis, modern equipment (a fluidized bed, for example) eliminates all problems in wet granulation. Dry Granulation: This process is used to form granules without using a liquid solution, because the product to be granulated may be sensitive to moisture and heat or does not compress well. Forming granules without moisture involves compacting and size reduction of the mix to produce a granular, free flowing blend of uniform size. Thus, the primary powder particles are aggregated under high pressure using swaying or high shear mixer-granulators. Dry granulation can be done in two ways: either a large tablet (slug) is produced in a heavy duty tableting press or the powder is squeezed between two rollers to produce a sheet of materials (roller compactor/chilsonator). When a tablet press is used for dry granulation, the powders may not possess enough natural flow to feed the product uniformly into the die cavity, resulting in varying degrees of densification. The double roller granulator (granulator-compactor) uses an auger-feed system that will consistently deliver powder uniformly between two pressure rollers. The powders are compacted into a ribbon or small pellets between these rollers and milled through a low-shear mill. When the product is compacted properly, it can then be passed through a mill and final blend before tablet compression. Finally, wet granulation involves the production of a granule by the addition of liquid binders to the powder mixture. Both continuous direct compression (CDC) and continuous mixing for the dry granulation processes involve the individual loading and accurate feeding of the API and a variety of excipients to a continuous blender

2020/06/30

IMPORTANCE OF MIXING

Mixing is at the heart of most production systems in the chemical process industry, pharmaceutical industry, food industry, and allied industries. It is of vital importance in processing solids, liquids, and gases in the polymer, glass, ceramics, building materials, pulp and paper, petroleum, and power industries and in industrial waste treatment systems. By definition, mixing is the process of thoroughly combining different materials to produce a homogeneous product. The resulting mixture in most cases is a combination of dissimilar materials. In some cases, a chemically homogeneous material may be mixed to produce a uniform blend of a desired weight or volume with consistent particle-size distribution, colour, texture, or other required attributes. Mixing is a critical process because the quality of the final product and its attributes are derived from the quality of the mix. Improper mixing results in a non-homogeneous product that lacks consistency with respect to desired attributes such as chemical composition, colour, texture, flavor, reactivity, and particle size. The wide variety and ever-increasing complexity of mixing processes encountered in industrial applications requires careful selection, design, and scale-up to ensure effective and efficient mixing. Improved mixing efficiency leads to shorter batch cycle times and operational costs. Today’s competitive production systems necessitate robust equipment that are capable of faster blend times, lower power consumption, and adaptability of equipment for use with multiple products. Moreover, in addition to carrying out mixing operations, many modern mixers are designed to combine different processing steps in a single piece of equipment: for example, coating, granulation, heat transfer, and drying. A mixer is no longer a generic production tool, but a critical and decisive business tool. This is because profitability and competitive advantage are dependent on subtle improvements in product quality through gains in mixing performance and efficiency. Good mixing is imperative for minimizing investment and operating costs providing high yields, and thereby enhancing profitability.

2020/06/30

​Universal Crusher Should Be Operated Correctly To Avoid Blockage

Guide: The crusher industry is still a new industry in China, which belongs to the initial stage of development. However, from the experience of a few decades, the speed is relatively fast, especially the universal crusher. Its application field is expanding continuously, and it is suitable for pharmaceutical, chemical, metallurgical, food, construction and other industries. It is known that the universal crusher adopts the impact crushing method. When the material enters the crushing chamber, it is impacted by six moving hammers which rotate at high speed. The crushed material is crushed by collision between the gear ring and the material. With the help of the air flow, the crushed material enters the crushing bag through the sieve hole, leaving no residue. The utility model has the advantages of high efficiency, low noise, reliable working performance and product quality, safe operation, low drug hygiene and consumption, etc. In recent years, with the improvement of technology, the omnipotent Chinese medicine crusher has simple structure, strong, stable operation and good crushing effect. All the inner walls of the shell have been machined to achieve smooth surface, which has changed the phenomenon of rough inner walls and powder accumulation of previous models, and made the production of drugs, food and chemical products more in line with national standards and meet the requirements of GMP.