Allegiant Health’s new, FDA registered, cGMP facility in Deer Park, New York, U.S.A. is fully equipped with the most technologically advanced, comprehensive array of pharmaceutical manufacturing machinery in the industry. Because of this significant investment in technology and equipment, the company is capable of producing a comprehensive range of product offerings in multiple dosage forms and potencies. Allegiant Health’s cost-effective production process includes utilizing high-quality materials, maximizing production and efficiently scheduling systems, all while emphasizing energy conservation. The company’s temperature and dust-controlled manufacturing and processing environment have been engineered to maintain total product integrity and quality throughout the entire manufacturing process. Read our Case Study for Process Improvement here.
Allegiant Health’s Pharmacy Department executes the batching, pre-weighing and auditing of raw materials which are measured and stored in stainless steel transfer totes. Allegiant Health isolates and stores material for production in controlled environments, delivering them for processing in precise measure by gravity feed into the mixing vessels. Purity, speed and precision are the foundation of the Pharmacy Department.
Allegiant Health possesses extensive blending capabilities. The company can accommodate a broad range of batch processing due to its multiple size mixing vessels ranging in capacity from 10 cubic feet to 125 cubic feet. As part of our Quality Control Program, each blending vessel is operated in its own isolated area.
All of the batching materials are provided pre-weighed, a process that is executed and audited by the company’s Pharmacy Department. The attention to detail and the tremendous skill possessed by this professional staff assures the absolute highest quality and consistency from batch to batch. All batches processed in the pharmacy blending area are stored and transferred in portable stainless steel totes. These transfer totes provide manufacturing with the ability to gravity feed the processed material directly into the compression equipment while maintaining isolation from the environment. This process minimizes the potential for contamination and ensures the purity of the ingredient blend.
Allegiant Health’s new facility is populated by the latest technology in compression equipment. Once the processed blends are released from blending, they are converted into solid dosage forms using state-of-the-art compression machines. Allegiant Health’s new facility features a dedicated, high-capacity compression area. Each state-of-the-art, high-speed compression machine is operated and maintained by a dedicated staff in its own isolated compression room.
To further enhance the quality of the compression process, all compressed dosage forms have the residual dust that naturally occurs during the compression process mechanically removed. Once the dust is removed, the compressed tablets are then inspected using highly sensitive metal detection devices. We routinely produce a wide array of tablet and caplet shapes and dosage sizes, with dimensions ranging from dosage sizes of 100 mg to over 1000 mg.
Allegiant Health has made significant investments in upgrading our coating capabilities in the new Deer Park, New York, U.S.A. facility. As a result, all solid dosage forms can be processed to accept an extensive variety of applied coatings. Our coating capabilities range from simple, clear film coat to multi-layer pigmented enteric coatings.
Allegiant Health operates high-capacity, technologically advanced, 60-inch diameter coating pans with multiple metered spray jets, providing a consistent and efficient coating operation. In keeping with the company’s high-quality standards, each coating machine is operated in its own dedicated room.
Allegiant Health features state-of-the-art pharmaceutical packaging technology that provides our customers with the ability to customize their brands across a multitude of potential packaging configurations. Allegiant Health employs rigid quality control protocols and all packaging operations follow current Good Manufacturing Practice guidelines for both active pharmaceutical and nutritional supplement ingredients.
Allegiant Health offers a broad spectrum of pharmaceutical packaging options including clear, transparent, translucent and opaque containers with tamper-evident screw, snap, and CRC closures. In additional to standard bottle fill configurations, customized product formulas and dosage forms can also be packaged in blister cards of various counts utilizing a push-through or CRC backing.
All primary and secondary packaging containers are carefully coded with batch lot identification and product expiration dates. To make certain the highest quality control standards are adhered too, each packaging line is isolated within its own, isolated packaging room. This isolation eliminates the possibility of product cross contamination.
Final customer presentation forms can be banded or bundled, tray displayed or packaged in case counts from 12 to 144 units.
Allegiant Health’s ability to provide this level of customized service and flexibility provides its customers with a broad range of unique pharmaceutical packaging opportunities to further enhance their brand’s equity.
Allegiant Health’s engineering team is dedicated to providing technical support within all aspects of the company’s day-to-day business operations. This highly skilled team of professionals provides guidance in areas that include implementing FDA regulations, validation assurance, quality control and maintaining a Good Manufacturing Practice (GMP) complaint facility. Our newly renovated facility is designed and built not simply to meet, but to exceed, the rigorous demands of the FDA. This self-imposed standard of quality enables the company to achieve clean-room level to ensure purity and clarity in all daily production activities.
Allegiant Health is fully equipped to produce a wide variety of solid dosage products from raw material to finished product. Significant investments have been made to acquire state-of-the-art equipment so the company’s team of skilled professionals can consistently perform advanced manufacturing protocols that feature high-speed compression, basic film and advanced enteric coating and comprehensive packaging in a wide array of formats. Allegiant Health’s engineering team is actively involved in all aspects of daily operations to ensure the safety, identity, strength, quality and purity of each and every product it manufactures.
The Allegiant Health Operational Management Team consists of experienced senior pharmaceutical industry executives who direct Allegiant Health’s success and provide guidance in areas that include:
Allegiant Health’s Operations Department oversees quality standards across every stage of operations, from innovation to manufacturing, and from packaging and distribution. This vigilance is key to making our policy of total client satisfaction a reality.
Allegiant Health has successfully implemented JD Edwards Enterprise ERP software across our operation platform. This advanced resource management system enables our company to manage and interpret operational data both in real time and over time. The system allows Allegiant Health to control product planning, identify operational efficiencies, track and control inventory and identify cost-saving measures that can be passed on to the consumer. The current system has ample capacity to manage current operations as well as future growth without operational interruptions.