Inhalation Products

Your most trusted partner for inhalation products

• Expertise: Experience handling HPAPIs, low-dose encapsulation and aerodynamic testing
• Reliability: State-of-the-art facilities and equipment ensuring highest quality inhalation products
• Agility: Entire product life cycle support in a fully automated environment

Our wide range of services for inhalation products

Analytical development

Our well-experienced drug product analytical development team supports development and commercial projects including release and stability testing with cGMP-compliant analyses, working with their counterparts covering drug substances to support your product. State of the arts GMP labs prepare for the aerodynamic tests and micro laboratory to perform the release testing and the environmental monitoring.

Scale up and clinical trial material production

Siegfried offers drug product clinical trial manufacturing under cGMP conditions at our Barberà del Vallès site, certified by national and international authorities. Our qualified team approves all GMP relevant documents and prepares the market release. ISO 13485 for medical devices is in place.

Commercial manufacturing and packaging

Siegfried supplies inhalation products packaged and ready to market worldwide in accordance with all cGMP, customer and market-specific requirements:

• Primary packaging for formulations with standard APIs and highly potent APIs inside isolators
  • Thermo and cold-form blisters, including on-line blister printing and anonymous blister, peel-off blister
  • Capability for perforated blister packaging
• Secondary packaging
  • Tamper evident serialized folding boxes (automated addition of devices available)
  • Blister printing (white stock)
• Tertiary packaging
  • Bundling and aggregation
  • Shipper case packaging and pallet aggregation

Technical capabilities

Our technical capabilities cover:

• Inhalation capsule based dry powder inhaler products (powder in capsule)
• Use of HPAPIs (down to 0.1 μg/m3)
• Equilibration capabilities with control on temperature and relative humidity.
• Capsule filler with net weight control and low dosage filling capabilities (down to 15mg) and able to work with hard gelatin or HPMC capsules.
• 100% automated visual inspection equipment available
• Specialized state-of-the-art aerodynamic lab intended for specific analytical techniques in the field of dry powder inhalers (fine particle mass vs. fraction, aerodynamic particle size distribution, delivered dose uniformity). The lab can test in the range of ±1°C and ±2%rH. Physico-chemical lab equipped with HPLC-MS and UPLC.
• Primary packaging: Peel blister capability with tightness control by gas (N2).
• Automated device addition in the packaging line and commissioning in ready-to-market configurations including serialization and aggregation for global supply
• Automated washing area

Siegfried is equipped with well-known and renowned brands like IMA, DEC, Telstar, Sensum, Diosna, Uhlmann and lab devices from Agilent and Copley.

Facilities

Each manufacturing room is individually controlled for relative humidity (down to 25% in manufacturing and 15% in primary packaging) and temperature, and suitable to be adapted to the needs of your product (down to < 10% rH). All facilities are routinely inspected by national and international authorities.