Services for Oral Dissolving Films

All services are purpose-built for oral dissolving film (ODF) and oral thin film manufacturing.

GMP ODF OEM contract manufacturing batches

GMP OEM / Contract Manufacturing

End-to-end production on qualified ODF machines — casting, drying, slitting, die-cutting, and primary packaging. We manage raw material sourcing, environmental controls, IPC, and release testing. Batch records, CoA, and full traceability are provided.

  • Clinical, pilot, commercial ODF batches
  • Moisture & thickness control
  • Taste-masking & API uniformity
  • Stability protocols (ICH)
Oral dissolving film formulation R&D

Formulation R&D

Polymer-plasticizer systems, sweeteners, and permeability modifiers engineered for rapid-dissolution or mucoadhesive buccal films. DOE-driven optimization for content uniformity and disintegration time.

  • API screening & solubility
  • Taste masking strategies
  • Mechanical property tuning
  • Disintegration & dissolution profiles
ODF machine installation and operator training

Installation & Training

On-site commissioning of ODF casting lines and packaging machines, SOP development, and operator training to hit target film specs faster.

Maintenance and retrofit for ODF equipment

Maintenance & Retrofit

Planned maintenance, spare parts, and performance upgrades for slitters, die-cutters, and ODF packaging machines to reduce downtime.

IQ OQ PQ validation for ODF machines

Validation (IQ/OQ/PQ)

Validation protocols tailored to oral dissolving film process steps — from equipment qualification to process validation with sound acceptance criteria.

Deliverables & Docs

We supply process descriptions, URS, FAT/SAT records, IQ/OQ/PQ protocols, batch records, cleaning validation, CoA templates, and change-control logs.

Confidentiality

Strict NDAs and controlled access ensure your ODF formulation, flavors, and API load remain confidential.