July 1, 2008
HCM is a leader in upscale process development and aseptic filling of liquid parenterals in syringes, vials and custom containers. HCM offers clients–from newly-established firms to large-scale commercial enterprises–high quality services and innovative technologies. Quality Services
Quality Services
Foremost among the services HCM offers are upscale process development and aseptic filling of syringes, vials, and custom containers. In addition to traditional fill and finish, HCM offers online vacuum filling and stoppering as well as lyophilization. HCM offers customers a Stability optimization Service (SOS) to assist them in determining the optimal container presentation for their products. HCM’s areas of specialization include difficult-to-process viscous and suspension products, microfluidization, homogenization, low-shear mixing, lyophilization, and aseptic diafiltration.
HCM’s Burlington, MA facility houses 60,000 ft2 of manufacturing, laboratory, cleanroom, and office space and employs 125 highly trained and dedicated personnel. Their state-of-the-art technology includes three Inova fill lines as well as a BOC Edwards lyophilization unit. HCM is capable of producing up to 150,000 syringes per day (0.5–20 mL) and 75,000 vials per day (0.1–100 mL). HCM is CGMP compliant, ISO 9001 and 13485 certified, and has been inspected by the USFDA for drugs and medical devices.
Equipment Specifications
Inova SV-122 Syringe Filler
One/ and two-head fillers to 50,000 units/day
Traditional online stoppering
Offline vacuum stoppering (Hypak box)
Low 30-mL hold-up volume
±0.03-mL fill precision
Inova H3-5V Syringe Filler
Three- or five-head fillers to 100,000 units/day
Online vacuum filling and stoppering
Bubble-free filling (no headspace)
Inova VFVM-3031 Vial Filler
Single “star wheel” to 75,000 units/day
Three-fill-needle format
Low 30-mL hold-up volume
Inline class 100 capping
BOC Edwards LyoMax3
Six product shelves
Two shelf interdistant settings: 69 mm and 140 mm
Lead/lag circulation pumps
Redundant systems (compressors, vacuum pumps)
Innovative Technologies
In 2006, HCM patented its innovative process for online vacuum filling and stoppering of prefilled syringes. This process, known as bubble-free filling, eliminates gas bubbles inside a syringe and thus offers several advantages. Recent studies have shown that bubble-free filling inhibits stopper movement under reduced atmospheric pressures, such as during airline shipping and highaltitude ground transportation. There is also evidence to suggest that bubble-free filling enhances the stability of oxygen-sensitive compounds, with which dissolved oxygen can negatively affect solution stability. Additionally, with bubblefree filling, proteins once thought too unstable for all but a lyophilized presentation may now be offered in liquid form because of the elimination or reduction of protein aggregation that results from air-to-liquid interfaces.
Our Commitment
At preclinical and commercial scales, HCM is committed to ensuring the highest level of quality products and services as well as regulatory compliance, on-time delivery, and prompt, professional communication. Whatever your needs, HCM will assist you in finding the very best manufacturing process to achieve your production goals. To learn more, visit our website at www.hyaluron.com.
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