Sterile powder filling

Development and characterization of powder blends and powder-based APIs, as well as the manufacture  of laboratory and technical batches, for example  for stability studies and preclinical in vivo studies.

Scale-up, manufacturing, and sterile filling of GMP batches of powder-based APIs and finished products with high flexibility in  primary packaging materials (e.g., vials, bottles, containers).

Following manufacturing and filling, products undergo terminal sterilization (e.g., by dry heat or gamma irradiation), are subsequently labeled, and stored under the appropriate  storage conditions (e.g., cold storage, light protection) in qualified and continuously monitored storage areas.

In addition, HWI performs labeling and secondary packaging for clinical studies (including randomization), as well as labeling, packaging, and serialization of commercial products entirely in-house.

We offer the manufacture  of technical batches, stability batches, and batches for clinical trials and commercial use with batch sizes of up to approx. 10,000 units.

In-process controls including flowability, mass, fill volume, container integrity, particle size, and visual inspections ensure consistent batch quality.

We additionally provide release testing and ICH-compliant stability studies, QP certification, and regulatory support throughout the entire drug development process.