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Intermediate
Potency
| Solid
Dose Mfg. | Solid
Dose Pkg. | Other
Mfg. and Pkg.
Our solid dose capabilities include the manufacture of tablets and
capsules, as well as the production of intermediate potency drugs in our
Containment
Suite.
Intermediate Potency
The Containment Facility is a specialized "plant within a plant",
designed to blend, tablet and coat high potency, dry blend pharmaceuticals
under contained conditions. The facility's production and environmental
conditions are continuously monitored to ensure optimal product quality.
The
Containment Facility follows the rigorous clean design principles targeting class 100,000
air. Its structural features are easily cleaned and not conducive to retaining
dust. It has its own HVAC system with a cascading air-flow, designed to
keep product dust that may be released during operation in the room where
it originates. In addition, HEPA filters on the supply and return air
ducts further reduce the risk of contaminating other rooms.
The facilitys standard equipment is enhanced to
run compounds of higher potency. All connections for the transfer of powder
are via a retractable hard pipe connection called a spool piece, which
is dust-tight. Most operations and cleaning systems are automated, to
limit operator exposure to the compounds. The Containment Facility also has its own purified
water system that meets USP codes.
Solid Dose Manufacturing
We specialize in the manufacture of tablet and capsule solid dose forms,
although we also have experience and capability to handle semi-solid and
liquid dosage forms. Our quality systems group issues and maintains raw
material, intermediate and product specifications from customers, while
the quality control laboratory handles the testing of those materials
during the production process.
Blenders
Our
blending capability includes jacketed Patterson-Kelley V-blenders equipped
with intensifier bars to assist in material distribution or to create
granulations, Bohle blenders, a tote tumble blender, and Nauta Vertical-auger mixers, designed to provide mixing
where gentle handling of the materials is mandatory.
Tablets
A
full complement of compression equipment enables short run and high
volume tablet production. Tablet Press equipment includes: Fette 2090,
Fette 2200, Mark II, Express and Hata presses.
Finishing capabilities include the application of
solvent or aqueous coatings. Printing capability exists for small and
large volume needs, including a rotogravure roll print and a high speed
printing system that can handle 5000 tablets per minute.
Capsules
Powdered drug encapsulation capability includes dual and single plug.
Equipment includes Bosch, H&K and MG-2 encapsulators. Our
Bosch is configured to fill a liquid or semi-solid into a hard gel
capsule. It can also fill tablets, beads, or powders.
Granulation
We offer fluid bed processing / drying capabilities in our
Aeromatic MP-5 system. Our Vector GMX 600 High Shear Mixer is also
available for granulation / mixing. Both are located in an
Intermediate Potency capable suite.
Solid Dose Packaging
Our solid dose packaging
capabilities include blister packaging and bottling. We exercise the same
care with packaging that we do with every other aspect of production. Our
Quality Assurance Group inspects all incoming packaging components and
issues and maintains all packaging orders, directions and component
specifications.
Blister Packaging
Equipment
includes a Klockner Blister line capable of thermoforming cards with a
wide range of sizes based on your requirements. We also have the
capability to do carding.
Bottling
Multiple packaging lines are available to provide our customers with
bottle packaging. Our highest-speed and most automated line has segregated
rooms for each stage of packaging - bottle orientation & cleaning,
filling & capping, and labeling & final box packaging.
We have both slat and slatless fillers for solid dose.
Compliance-designed bottling equipment with rapid changeover
capability provides a wide range of counts and sizes to meet most any
customer need. Multiple bottle fill lines enable both short run and high
volume capability. Integrated vision systems automatically ensure proper
fill counts and labeling; multiple labels and formats can be applied.
An automated case packer and palletizer ensure cost effective and efficient
operations.
Other Manufacturing and Packaging
Ointment/Liquid
Our Ointment and Liquid Manufacturing capabilities include two 1000 and
one 2000 gallon Cherry Burrell jacketed mixing tanks. We also have a variety
of Cherry Burrell and Groen jacketed mixing vessels ranging from 200-300
gallons. To compliment the larger tanks, we have several 200 and 172-gallon
"Day" holding tanks, including several with Lightnin' mixers
and heating capabilities.
Liquids Packing
We have a wide range of proven bottle filling capability, ranging from
1 oz to 500 ml bottles across various viscosities. Our bottle handling
equipment can work with glass or plastic bottles.
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