Medical Device Manufacturing

LSNE Contract Manufacturing has two cGMP medical device manufacturing facilities located in New Hampshire capable of producing reagents, diagnostics and medical device components and products. With development services available onsite, LSNE is uniquely positioned to produce material from prototype to final product. LSNE can partner with you to develop a lyophilization cycle, optimize your current aseptic formulation or lyophilization cycle, and also provide process development services such as feasibility studies and validation activities, if required.

LSNE has over 15 years of experience in the medical device industry, with five successful FDA inspections, including the most recent FDA QSIT inspection in 2011, where no 483’s were issued. Our highly experienced and trained personnel combined with our automated equipment provide quality and consistent products to our clients. In order to streamline workflow and communication, upon contract execution you are assigned a dedicated project manager to work with you from initial technical transfer through final product release.
 
 

Collagen Sponge Manufacturing

  • Formulating viscous solutions, slurries, and suspensions
  • Collagen cross linking

 

Aseptic Formulation Capabilities

  • Viscous solutions, suspensions and slurries
  • Temperature controlled
  • Collagen purification

 

Fill Finish Capabilities

  • Two automated fill lines
  • Hand filling in biosafety hood controls
  • Vials, ampoules, custom containers
  • Crimp top and screw cap vials
  • Batch sizes up to 25,000 vials
  • Performed under controlled conditions

 

GMP Lyophilization Capabilities

  • 17 non-aseptic lyophilizers – 4 ft2 to 260 ft2
  • Capable of handling organic solvents

 

Medical Device Manufacturing Support Capabilities

  • Grinding and cutting
  • In-Process and Final Product Testing and Inspection