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Posted: November 21, 2008
Microfluidics Introduces New Line of Microfluidizer High-Shear Fluid Processors
(Nanowerk News) Microfluidics has introduced a new line of Microfluidizer® high-shear fluid processors designed specifically for the pharmaceutical and biotechnology industries. The comprehensive line of 24 standard pre-engineered models is the widest available on the market and allows companies to meet specific processing requirements of the particular drug being manufactured. The processors are offered in aseptic, enhanced, and basic versions, which are available in various pressure ranges and with two different motor sizes, 25 and 50 hp. All are guaranteed to accurately scale up from lab and pilot-scale Microfluidizer processors, and may be scaled up from other processors as well.
Microfluidizer® processors are used extensively in the pharmaceutical and biotechnology industries to manufacture a wide range of drugs (including cancer therapeutics, vaccines, and anesthetics) delivered through multiple delivery platforms such as injectables, inhalables, parenterals and transdermals. The processors generate a controlled shear rate which allows bacterial, plant, and mammalian cells to be safely and efficiently disrupted. They also impart the highest shear rates of any fluid processor on the market today in order to achieve the desired product quality for nanoemulsions, nanodispersions, liposomes and nano/microencapsulation in the fewest number of passes.
“Microfluidics is excited about offering the widest range of production machines on the market,” says Microfluidics’ Product Manager, Dave Gucwa. “No other company offers this level of performance and industry specificity. Every company’s processing needs are different, and we can now offer variations that suit a wide variety of requirements in such parameters as pressure, temperature control, feed techniques, process monitoring, and FDA 21 CFR part 11 compliant data recordkeeping. Whether the customer is a major producer of injectables or a small startup firm looking to produce clinical batches, Microfluidics has a processor that will make it easier to do the job.”
All 24 processors come with the Ultra Clean In Place (UCIP) system, eliminating the need for disassembly for cleaning (COP), as well as written certifications that all product contact surfaces have been ground to a 20Ra surface finish, electro-polished and passivated. In keeping with cGMP guidelines, each processor comes with IQ/OQ documentation, a document turnover package (including material and calibration certificates for validation support), and on-site start-up (and training), and is CE compliant. All processors include a skid-mounted pharma-grade feed pump and a sanitary flush diaphragm pressure transducer.
Designed to provide superior results for pilot and production environments where sterile processing is required—for example, manufacture of injectables, inhalables, and vaccines—the Aseptic BioPharmaceutical Microfluidizer® Processor uses a steam-in- place sanitization step to provide verifiable sterility that always passes the Sterile Fill Test.
The aseptic processor’s onboard documentation system includes data recording and transmission that can be fully integrated with the plant’s computerized control and monitoring system. The data collection system provides validation support. In addition, the aseptic system’s highly secure batch records are 21 CFR part 11 compliant. Aseptic processors come in 10,000 and 20,000 pounds per square inch (psi) models in 25 and 50 hp versions. The 50 hp model is available with synchronous or constant pressure operating styles. Hazardous duty versions are available.
Enhanced BioPharmaceutical Microfluidizer® Processors have instrumentation that is virtually identical to aseptic models, but are designed for manufacturing products that do not require validatable sterility, or those that will use downstream sterile filtration. All instruments and valves are sanitary grade and BPE compliant. Enhanced processors contain the same onboard data recording and physical monitoring system as the aseptic version. Enhanced processors are available in pressure ranges of 10,000, 20,000, or 30,000 psi, in 25 and 50 hp versions. The 50 hp model is available with synchronous or constant pressure operating styles. Hazardous duty versions are available.
Basic BioPharmaceutical Microfluidizer® Processors are designed for economical manufacturing of clinical and production batches. Producers of oral suspensions frequently choose one of the basic processor models. Basic processor models include 10,000, 20,000, or 30,000 psi versions, in 25 or 50 hp versions. The 50 hp model is available with synchronous or constant pressure operating styles. All product paths, instruments, and valves are sanitary grade and BPE compliant. Available upgrade options include pharma-grade heat exchangers, inlet strainer, factory acceptance testing (FAT), site acceptance testing (SAT) with IQ/OQ execution, temperature sensing with digital readouts, and motor starter panels.