Consider the selection of medicinal spray dryer

Drug production in the pharmaceutical industry is one of its main tasks, the importance of drugs and drug material differences in the nature, constitute the special requirements of pharmaceutical production. Currently, GMP pharmaceutical production has begun to be implemented as a system and forced the implementation of the regulations. The implementation of GMP involves the design, manufacture, installation, use, management, verification, and other links. As one of the pharmaceutical equipment, spray dryer how to adapt, to take this opportunity to share our views and practices about and wrong, please correct me, in order to jointly enhance the development.
1 Spray Dryer features:
Spray Dryer is a liquid material into fine particles by spraying it in the drying chamber with hot air contacts the water evaporates quickly, so direct access to powder products plant. The device performance has the following characteristics:
﹙1﹚ can be obtained directly from the liquid raw material powder products, general, high-speed centrifugal spray drying the particle size D50 in the 60 ~ 125μm (ie 250 to 120 mesh) range, pressure spray D50 particle size of dry fog at 125 ~ 250μm (ie 120 to 60 mesh) range.
﹙2﹚ the drying time is very short, usually only 5 ~ 40Sec.
﹙3﹚The temperature of the droplet drying process is not high, the product of heat-affected small, not prone to changes, such as protein, vitamins, active ingredients loss of oxidation and other defects, the heat-sensitive materials, biological and quality of drugs can basically close to the vacuum drying standards.
﹙4﹚ the product remained similar to the spherical droplet, has a good dispersibility, fluidity and solubility.
﹙5﹚ changing the liquid water content of raw materials or spray drying conditions, you can adjust the product within a certain range of residual moisture within the particle size, bulk density, the production process is simplified, easy control and management.

The characteristics of pharmaceutical materials: chemical compound classes, whether drugs, biological products, or herbal, natural medicines belong to a strong heat-sensitive materials, air temperature is relatively low, complex composition, in particular the nature of herbal variations in the material of all varieties, peptides, polysaccharide, protein, high moisture absorption, viscosity, softening point is low, and to ensure the active ingredients, active ingredients is not destroyed and other properties on medicinal dryer a higher requirement.
3 The basic requirements of GMP equipment:
﹙1﹚ equipment layout should be compatible with the process, production capacity should be compatible with the bulk, design and manufacturing process requirements should be consistent.
﹙2﹚ the equipment should be easy to operate and maintenance, easy cleaning and disinfection. Not only to prevent foreign matter and bacteria in the inflow of the outside world should have the line cleaning, line sterilization function.
﹙3﹚equipment and materials, the contact parts of the material should be non-toxic, corrosion resistance, not with material from a chemical reaction, without shedding coatings, fibers, and particulate matter.
﹙4﹚ the device wall must be smooth, non-sag structure, all corners should be arc transiti
﹙5﹚ device drivers stable, noise, dust, waste water discharge should meet the relevant requirements.

﹙6﹚ closed the device itself is good, all lubricants, coolant should be avoided and the material, packaging container in contact.

Medicinal Spray Dryer types and basic functions: According to the characteristics of spray dryer; pharmaceutical properties of materials; and GMP requirements of the equipment be considered comprehensive for most materials in terms of:
A, Model: The open cycle, vertical drop and flow patterns, high-speed centrifugal rotary spray dryer is recommended, especially for Chinese. If the requirements of dry powder particle size of 100 mesh (150μm) above, the optional pressure nozzle spray dryer.
B, equipment should have the basic functions:
﹙1﹚ to ensure the dry product is not contaminated, all with the material, hot material contact parts made of stainless steel, stainless steel, pharmaceutical grade materials should be adapted to pH (PH value) requirements.
﹙2﹚ in order to meet the health requirements, the tower into the air subject to sterilization filtration, purification degree in addition to 100 consider the injection, the remaining 10 million can be considered ... 300,000. Drying tower should be under positive pressure in the run. Finished in the bottom of a cone dryer output, and collected in a clean room for product packaging.
﹙3﹚ to ensure that emission levels comply with environmental requirements, removal should be considered secondary, the first high-level cyclone powder recovery by the second stage can be dry or wet dust collector bag filter for recovery last meal. For product hygroscopicity is strong and the production of many varieties dryer to wet scrubber is more appropriate.
﹙4﹚ the device itself airtight, and no contact with the material sources, the inner wall is smooth, the structure as simple as possible, easy disassembly, easy to clean, smooth operation
5 Medicinal drier conditions of selection and the content of our customers:
﹙1﹚ equipment, production capacity: hour water evaporation capacity is the ability to target the dryer, and directly affect the investment size and equipment utilization. Converted to an annual index in the dry, the dryer should be sufficient to improve the running time rate, long time as far as possible continuous production, reduce unit hour production requirement. The ability of the development of reserves expected to be appropriate.
﹙2﹚Drying process parameters: a) inlet temperature: in the materials could endure conditions as possible, exhaust air temperature to meet the request of the finished product moisture content to minimize the degree of drying, however, into the exhaust temperature, and will help improve production capacity and thermal utilization. b) liquid Solid content, improve the feed concentration to reduce initial moisture content, not only in the equipment under the same amount of water evaporation can increase the production capacity of more than too dry, and can make the product bulk density increases, the increased dry weight.
﹙3﹚Hot air systems: hot air in energy, pharmaceutical companies generally have a steam conditions and medicines into the air temperature is not high, the economy can be the most suitable for steam + electricity, other issues such as electricity, heating fuel or gas stove can also be indirect, depending on the customer with possible to be. Limit the maximum temperature of hot air system should consider leaving room for a variety of replacement of the inlet air temperature was adjusted possible, and the other high-temperature air can also be used for sterilization of equipment, play a similar effect of dry heat sterilization, taking into account heat to high temperature filter and a reasonable premise of the economy, it is recommended to design the hot air system at 2000C.
﹙4﹚ electrical control requirements: as a production machine, to ensure product quality from production operations and fluctuations in human factors, automation should be considered necessary.
a) inlet air temperature controlled, temperature controlled ventilation is needed, especially in exhaust temperature, the stability of the residual moisture content of the products have a direct impact on stability. As to accuracy, the set temperature conditions, the temperature ± 5 ℃, exhaust air temperature of about ± 1.5-2.5 ℃ economic appropriate. b) centrifugal atomizer speed control: For variety of materials as viscosity, solid content of the change and adjust the product to control the size, frequency stepless speed regulation function of the nebulizer should be considered. c) into the exhaust fan operation control: In order to improve the operating strength and direct and convenient, could be considered in the electric control room remote control butterfly cutting control air flow, such as variable frequency adjustment fan speed, directly change the fan flow, the more savings in fan power of 30% advantages. d) other control require the use of conventional manual control or have higher expectations can be.
﹙5﹚Used to improve the operating range, enhanced drying effect, the necessary attachment to consider:

a cold air system: drying machine design and manufacture of air conditioning distributor is not the right thing, the top roll and hanging eddy current materials materials (commonly known as the Pan-top) is have occurred, with a cold wind from the ventilation systems clean the air duct into the people, but also can prevent the rise in the cooling tower spray powder device, improve and solve the problem of pan-top, regulation and control is extremely convenient. the tower wall jacket cooling system: the thermal denaturation strong, low softening point material, such as the tower in the long run the wall temperature is higher than the material softening point, the adsorption powder melting wall again, using the tower wall jacket cooling system for the tower top wall for natural ventilation or forced air cooling, the tower wall softening point temperature is always below the temperature in the material, the effect is obvious. tower wall air sweeping device: the role of electrostatic adhesion of the material as aggregates, absorption is normal in the tower wall, but the need for timely clean-up down, or to the product’s color and variability, with the tower wall vibration (such as hammer, air hammer) can also be powder vibration absorption tower wall came down, but the rapping regional limitations, can not do a comprehensive clean air sweeping device using the tower wall, with the clean air around the tower straight from the slow rotation of the injection tube cone, many blow out of the nozzle, the total area of ​​the tower straight cone accumulation of material on the purge, the effect is obvious. pneumatic conveying system: the dried powder, due to high temperature, such as bags tend to have an immediate lump condensation occurs, together with powder received directly from the cyclone, the drying machine layout and structural constraints, received powder clean room must be very close to the drying machine, which often results in the production process plant layout of the inconvenience of the arrangements, the use of pneumatic conveying systems, out of the main cyclone powder sent to the hopper for clean room packaging, the use of dehumidification of air purification thermostat While long-distance transport of product for product cooling. CIP cleaning system: the importance of cleaning is self-evident, the use of CIP cleaning system can effectively address the full access to all parts of the powder self-cleaning, to ensure that different varieties of materials are not cross-batch contamination and mixing stage batch cleaning reliability, improve the cleaning effect and improve the operation conditions. CIP cleaning system with multiple cleaning medium (cold water, hot water, solvents, deionized water, compressed air, low pressure steam) recycling of hot air chamber; drying tower; the main cyclone and the air inlet pipe; pneumatic conveying of small cyclone separator and piping out of the four work areas, manually or automatically by setting operation. Reliable and effective.

These attachments have a clear target, we have customers in parts of drying machines configured. The use of equipment has been put into the test, to achieve the desired results. Of course, these ancillary device for increasing energy, equipment manufacturing complex structure, increase the difficulty, cost will increase.

New drugs requires the development and production process improvement will drive innovation and development equipment, as equipment design and manufacture of specialized units, we are happy with the pharmaceutical industry must also on the front to maintain close cooperation with people, learning from practice and continue to industry with advanced equipment and good quality and cheap services, both for the development of their own areas of expertise, more of the pharmaceutical industry to contribute to the development of the common.