Services & technologies

Services and technologies

End-to-end API value chain management, leveraging science, technology and know how to deliver rapid, right quality value add solutions.
Our goal is to understand the environment in which we operate and combine this with close listening to our customers in order to deliver high-quality, value-added, safe and effective medicines. An example of this broadening of capabilities is Sterling’s SCIENCE BEFORE SALES – SB(4)S program, which provides greater insight into products and their performance, enables faster economic decision-making for clients and offers an end-to-end partnership across research, development and API manufacturing. The flexibility of our customized solutions enables us to build long-lasting relationships, create sustainable value and support our customers’ success.
Our goal is to understand the environment in which we operate and combine this with close listening to our customers in order to deliver high-quality, value-added, safe and effective medicines. An example of this broadening of capabilities is Sterling’s SCIENCE BEFORE SALES – SB(4)S program, which provides greater insight into products and their performance, enables faster economic decision-making for clients and offers an end-to-end partnership across research, development and API manufacturing. The flexibility of our customized solutions enables us to build long-lasting relationships, create sustainable value and support our customers’ success.
SONO-CRYSTALLIZATION

Utilizing the most innovative technologies - whether proprietary, in-house, or outsourced - Sterling is able to engineer products by tailoring morphology, particle size, and solid-state properties.

SONO-CRYSTALLIZATION

Proprietary technology involving the application of ultrasound energy to control the nucleation and crystal growth of a crystallization process.

Recently Sterling acquired the exclusive worldwide licensee of the Sono-Crystallization technology and its associated Intellectual Property.

Utilizing the most innovative technologies - whether proprietary, in-house, or outsourced - Sterling is able to engineer products by tailoring morphology, particle size, and solid-state properties.

SONO-CRYSTALLIZATION

Proprietary technology involving the application of ultrasound energy to control the nucleation and crystal growth of a crystallization process.

Recently Sterling acquired the exclusive worldwide licensee of the Sono-Crystallization technology and its associated Intellectual Property.

Equipment

  • NON-GMP and GMP-PLANT located in Perugia (Italy) site
  • Ultrasonic amplification system 9SNC-01
  • Dedicated vessels for solvent and anti-solvent systems
  • Automated process
  • De-agglomeration (twin screws feeder) system available, if needed

Manufacturing Process:

  1. Raw Materials
  2. Dissolution
  3. Crystallization
  4. Filtration
  5. Drying
  6. De-agglomeration
  7. Analysis
  8. Storage
  9. Release

Equipment

  • NON-GMP and GMP-PLANT located in Perugia (Italy) site
  • Ultrasonic amplification system 9SNC-01
  • Dedicated vessels for solvent and anti-solvent systems
  • Automated process
  • De-agglomeration (twin screws feeder) system available, if needed

Manufacturing Process:

  1. Raw Materials
  2. Dissolution
  3. Crystallization
  4. Filtration
  5. Drying
  6. De-agglomeration
  7. Analysis
  8. Storage
  9. Release

JET-MILLING MICRONIZATION

  • In-house, R&D scale (non-GMP), equipment located in Italy site 100 mm jet-mill (Processable qty: from approx. 30 to 300 g)
  • In-house, GMP suite, located in Malta site 200 & 300 mm jet-mills (Processable qty: from approx. 2 up to 100 Kgs)
  • Partner(s) CMO, GMP service, also available 50-100-200-300 mm jet-mills (Processable qty: from approx. 25 up to hundreds Kgs)
  • Particle size control: “wet” & “dry” Malvern systems

CONTROLLED-PRECIPITATION

It allows to drive nucleation within a tight range of particle sizes and explore different morphologies of crystals.

Examples of process critical parameters:

  • Solvent/anti-solvent system
  • Stirring rate
  • Drying conditions

JET-MILLING MICRONIZATION

  • In-house, R&D scale (non-GMP), equipment located in Italy site 100 mm jet-mill (Processable qty: from approx. 30 to 300 g)
  • In-house, GMP suite, located in Malta site 200 & 300 mm jet-mills (Processable qty: from approx. 2 up to 100 Kgs)
  • Partner(s) CMO, GMP service, also available 50-100-200-300 mm jet-mills (Processable qty: from approx. 25 up to hundreds Kgs)
  • Particle size control: “wet” & “dry” Malvern systems

CONTROLLED-PRECIPITATION

It allows to drive nucleation within a tight range of particle sizes and explore different morphologies of crystals.

Examples of process critical parameters:

  • Solvent/anti-solvent system
  • Stirring rate
  • Drying conditions