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
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.