Ophthalmics

Your most trusted partner for ophthalmics

• Expertise: Dedicated Development Center offering development and scale up services
• Reliability: 95+ years experience as a reliable ophthalmic partner
• Agility: Providing tailored solutions for complex formulations and processes

Pharmaceutical development

Our flexible platform offers the development of standard and complex ophthalmic formulations. Siegfried’s development experts support you with:

• Evaluating primary packaging materials
• Selecting the right sterilization system (filtration, steam sterilization, dry heat, chemical sterilants or gamma irradiation)
• Identifying the best mixing and dosing system (e.g. peristaltic or rotary piston pumps)
• Studying production material and packaging interactions with your formulation and supporting leachables and extractables studies
• Evaluating terminal sterilization effects

Analytical development

Our well-experienced drug product analytical development team supports development projects with cGMP-compliant analyses, working with their counterparts covering drug substances to support your product at every phase in the development process. With access to the analytical resources of our global network, analytical services range from development activities, formulation support, stability testing to method validation and commercial GMP batch release testing.

Scale-up and clinical trial material production

We take your process to the next manufacturing level quickly and smoothly regardless of your starting point, whether it is a new, modified or existing formulation generated by our pharmaceutical development team. Siegfried offers cGMP-manufacturing of all scales ranging from very small quantities to pilot scale batches depending on your specific needs. A qualified person approves all GMP relevant documents and makes the market release.

Siegfried offers drug product clinical trial manufacturing under cGMP conditions at our Irvine and El Masnou facilities, serving all the countries where your clinical study is carried out utilizing fixed or disposable technologies.

Process and analytical method transfer

Siegfried plans and designs processes from an early development phase, ensuring a successful scale-up and transfer to commercial production. Our adaptable and scalable solutions cater to a wide range of formulation and project needs, encompassing both ANDA and NDA products. We offer specialized knowledge in equipment and process design to support your project seamlessly throughout every stage of manufacturing. Siegfried supports complete process transfer of your product to our US or EU locations. Services include:

• Transfer of analytical methods (including cleaning validation)
• Transfer and/or scale-up of the production process
• Process qualification and validation
• Manufacture and release of registration batches
• Packaging according to customer specifications
• Stability testing according to ICH
• Support in registration activities
• Life cycle management

Commercial manufacturing and packaging

Siegfried supplies ophthalmics packed and ready to market worldwide in accordance with all cGMP, customer and market-specific requirements:

• Primary packaging
  • Bottles (round, oval, glass BTC)
  • Tubes (alu, laminated foil)
  • Preservative-free bottles (Aptar®)
• Secondary packaging
  • Labeling of bottles
  • Tamper evident serialized folding boxes
  • Pouch packaging
• Tertiary packaging
  • Bundling and aggregation
  • Shipper and pallet aggregation

Technical capabilities

Our technical capabilities cover:

• Compounding of sterile ointments, gels, suspensions and solutions
• Filling in tubes and bottles (bottle/ tip/ cap)
• Manufacturing and filling of preservative free forms in multi-dose bottles (using Aptar® OSD-opthalmic squeeze dispenser)
• Final packaging in ready-to-market configurations including serialization and aggregation
• In-house technical expertise and state of the art microbiology and chemistry laboratories for both incoming raw materials, in-process and finished product testing capability services

Siegfried is equipped with well-known and renowned brands like Waldner, Fryma, IWK, Bausch + Ströbel and Uhlmann.

Facilities

All facilities are routinely inspected by national and international authorities.