Для обеспечения оптимальных поставок продукции, фармацевтическая промышленность обязана соблюдать строгие условия завода-изготовителя. "Важно обеспечить, чтобы такие переменные, как температура и влажность, тщательно контролировались, чтобы не сказывались на качестве продукции. Компрессоры играют важную роль в этом, поскольку они являются основным моментом для обеспечения точности охлаждения. Незначительный провал в этих областях может критически сказаться на качестве продукта, и тем самым сделает его непригодным для распространения на рынке, что приведет к значительным материальным и денежным потерям.”- рассказывает Ravichandran Purushothaman, Президент Данфосс в Индии.
Сжатый воздух является одним из наиболее важных моментов в
в фармацевтической промышленности, который влияет на качество и безопасность производства в данном секторе.
Технологии безмасляного сжатого воздуха Ингерсолл Рэнд помогают фармацевтическим производителям максимально повысить надежность и эффективность продукта.
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In order to ensure optimum supply of products, the pharmaceutical industry is required to follow a strict mandate on the processing conditions of the manufacturing plant. “It is essential to ensure that the variables such as temperature and humidity are accurately monitored to ensure that the qualities of the products are not affected. Compressors play an important role in this regard as they are the core unit to enable precision cooling. A minor lapse in these areas will critically affect the performance of the product, and thereby make it unfit for distribution in the market leading to large amounts of material and monetary losses.” informs Ravichandran Purushothaman, President, Danfoss India.
Compressed air is one of the most critical utility in the pharmaceutical industry as many of its applications involve direct product contact some examples of compressed air applications are de-dusting and spray coating of tablets, pressurising mixing and holding tanks, pressurising liquid product through filters and fill lines, operating control valves and pneumatic cylinders in automated production lines, packaging of capsules, tablets, vials, ampoules, tubes and bottles, nitrogen generation.
According to Jatinder Kaul, National Sales Leader- Sales, Compression Technologies and Services, Ingersoll Rand, India, “The compressed air system must be properly designed and built from the outset, the initial validation testing and ongoing monitoring of compressed air is also vital to assuring both the quality and safety of the pharmaceutical product.”
The quality standards for a pharmaceutical facility are best defined as a composite set of specifications that are site-specific based upon the point-of-use requirements. (US FDA or GMP guidance and ISO air quality standards).
“Ingersoll Rand Class 0 Oil-Free compressed air technologies help pharmaceutical manufacturers adhere to this regulation by ensuring production processes remain 100 per cent free of compressor-created contaminants and aligns with GMP and USFDA standards. Our innovative intellisurvey assessment
tool allows us to also monitor and analyse current air system performance in order to determine solutions that will maximise system reliability and efficiency,” said Jatinder about compressed air technologies.
“It is recognised that there are two main sources of contamination in compressed air systems. The main
contaminant source being atmospheric air, which is drawn in to the system and the second major source being the compressor, which traditionally uses oil for lubrication and cooling and can carry over downstream. If not treated, this oil will pass freely through the system to the critical control point. Most pharma companies are switching to oil free compressor technologies which allow the users to remove fully, one of these major sources of contamination,” said Pankaj Kumar, Business Line Manager and Industrial Products Group, Gardner Denver Engineered Products India
“Some pharma companies may select 100 per cent oil free air compressors. These compressors do not contain oil at all, whereas some oil free compressors contain oils within gearboxes and other non-air side areas of the compressor. In terms of risk analysis, pharma producers should consider the potential impact of this should there be any failure of internal sealing arrangements or even leakage of these
lubricants and oils,” claims Pankaj.
In pharmaceutical industry, pumps are required at all stages like processing, unloading, dosing, mixing or transferring individual ingredients or the final product. As a full-line supplier Grundfos offer thoroughly tried and tested sanitary solutions for every conceivable pump application including upstream processes, downstream processes, CIP or SIP-systems, clean utility systems. “Common to all Grundfos solutions is highly reliable performance that guarantees peace of mind in even the most delicate and critical processes. The electropolished interiors of our unique sanitary pumps are free from edges, seams and screw heads to prevent bacteria particles from accumulating, which in turn safeguards your product quality and brand reputation,” asserts Shankar Rajaram, Vice President - Business Development, Sales, Grundfos Pumps India Pvt. Ltd.
As shear-sensitive liquid biopharmaceutical products have proliferated; the industry has paid more attention to pump technology, from filtration and fluid transfer, to formulation, dispensing and fill or finish. “While traditional pumps of the centrifugal or piston variety, for example have all shown steady improvement in design, materials and finishes, more sensitive and easy-to-clean peristaltic, lobe pumps have captured significant market share as well,” says Jayashree Ananthan, Director Technical Service Viking and WFT India & Middle East, Idex Fluid and Metering Technologies.
Digital Dosing Solution from Grundfos
Grundfos offers a wide range of dosing pumps representing state-of-theart technology. Digital Dosing solutions (SMART Digital) set new standards in liquid chemical handling and accuracy. The operator can easily install and set up the pump to discharge exactly the quantity of dosing liquid required for the process in a unique drive- and flow-control management concept. The setting of the pump is displayed in ml/h, l/h or gph and the operation mode is easily identified by means of icons.
Sterilobe pump from Idex Fluid and Metering
Talking about the offering for pharma industries Jayashree said, “The basic design of the pump has been made keeping in mind of pharma industry requirements. Wright Flow Technologies offers several such pumping solutions and of them all, the Sterilobe pump design has been the most appropriate with special features demanded by pharmaceutical liquids.”
Features of Sterilobe Pump
This pump is EHEDG certified for CIP and SIP which certifies the pump for bacteria tightness.
The casing ID has one side of the port with special 45 degcut to enable easy drain. When the pump is mounted vertically with this flat face at the bottom, this allows easy drainability with zero hold up liquid.
There is big access to the stuffing box from the back side of the casing. This enables easy external cleanability and easy removal of seals reducing downtime to max 10 min, and further without having to disturb/dismantle piping or mounting.
The front cover joint has a profile that follows the id of the casing, thereby minimising the exposed crevice between the casing and the cover plate. More Hygienic design.
Minimum surface finish of 0.6um which is better than the normal finish of 0.8um, again providing the best hygienic feature.
Carbon Vs Sic Standard seal faces with EPDM FDA approved elastomer as standard in pump
Four lobe rotor designs offers better efficiency due to larger contact surface area with casing at the same time low shear effect on product.
Foot on Bearing Housing making it easier for pump to be mounted vertically or horizontally by just changing foot position.
A rotor retainer is cross haired and is flush thereby ensuring no liquid retention when pump is stopped at any angle.
Stating the precise controlling of the system parameters that suit the unique requirements of the pharmacy processing sector for a clean room application, Ravichandran said as follow:
Pressure Independent Balancing and Control Valves (PIBCVs)
The PIBCVs help in providing the perfect control and automatic hydronic balance which maximises the effective functioning of the processing plant. The versatility of the Danfoss AC drives lies in the fact that it is independent of motor manufacturers which contributes
to its ability to adapt to any motor technology.
Variable Frequency Drives (VFDs)
The Danfoss VFDs help in controlling the chilled water and the hot water valves of the machinery and the fan speed to ensure that the requisite conditions are met
Turbocor (oil free compressor) compressor is used in oil free chillers and with inbuilt variable speed control which helps precise temperature can be achieved in labs with excellent efficiency.
Variable Speed Condensing Unit
Variable Speed Condensing Units have unique feature of controlling precise temperature and load requirement of pharma cold rooms.
Ravichandran opines, “As an industry leader in energy efficient solutions, we also focus on ensuring that our products and solution require minimum energy input without compromising on its performance, thereby contributing to the growth of the sector by reducing the incurred monetary and environmental costs.”