Leiters stands apart by focusing on one singular purpose:
bringing health to outsourcing.

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Processes that ensure the highest quality 503B outsourced products.

  • Prior to commercialization, each new product completes a development process including independent laboratory confirmation of identity, potency, and sterility.
  • Use of fully validated product-specific sterile filtration during production to enhance Sterility Assurance Level (SAL).
  • Beyond Use Dates (BUDs) established based on product-specific stability testing of both chemical and microbiological characteristics.
  • Potency, bioburden, endotoxin and sterility testing by an independent laboratory on 100% of lots produced.
  • Independent laboratory testing of chemical and microbiological characteristics including ID, bioburden, and endotoxin of all incoming powdered active and inactive ingredients.

Your journey to better medicine begins here.

Click below to view our available 503B services.

 

Facilities and Equipment that Ensure the Highest Quality 503B Outsourced Products.

  • Use of Germfree Vertical Laminar Flow Hoods which offer a high degree of localized control for critical processes, providing a sterile environment for the handling of materials and a work area continuously bathed in Class 100 HEPA-filtered air to protect the product from contamination.
  • Bioquell SeQure™, a fully validated automated biodecontamination system which uses vaporized hydrogen peroxide to eradicate the bioburden of microorganisms and other contaminants on all materials entering the aseptic core.
  • Negative-pressure isolators, fume hoods, biosafety cabinets for containment of powdered APIs during formulation.
  • Fully validated facility including extensive IQ, OQ, and EMPQ activities performed and/or reviewed by industry experts.
  • Validated building automation system to alert Quality, Production, and Facility personnel of cleanroom condition changes.

Processes that ensure the highest quality 503B outsourced products.

  • Prior to commercialization, each new product completes a development process including independent laboratory confirmation of identity, potency, and sterility.
  • Use of fully validated product-specific sterile filtration during production to enhance Sterility Assurance Level (SAL).
  • Beyond Use Dates (BUDs) established based on product-specific stability testing of both chemical and microbiological characteristics.
  • Potency, bioburden, endotoxin and sterility testing by an independent laboratory on 100% of lots produced.
  • Independent laboratory testing of chemical and microbiological characteristics including ID, bioburden, and endotoxin of all incoming powdered active and inactive ingredients.

Your journey to better medicine begins here.

Click below to view our available 503B services.

 

Facilities and Equipment that Ensure the Highest Quality 503B Outsourced Products.

  • Use of Germfree Vertical Laminar Flow Hoods which offer a high degree of localized control for critical processes, providing a sterile environment for the handling of materials and a work area continuously bathed in Class 100 HEPA-filtered air to protect the product from contamination.
  • Bioquell SeQure™, a fully validated automated biodecontamination system which uses vaporized hydrogen peroxide to eradicate the bioburden of microorganisms and other contaminants on all materials entering the aseptic core.
  • Negative-pressure isolators, fume hoods, biosafety cabinets for containment of powdered APIs during formulation.
  • Fully validated facility including extensive IQ, OQ, and EMPQ activities performed and/or reviewed by industry experts.
  • Validated building automation system to alert Quality, Production, and Facility personnel of cleanroom condition changes.