Unstable-active formulation
Galenic strategies, antioxidants, chelators and process controls designed to protect sensitive actives throughout shelf life.
CDMO partner
One team to turn an idea into a manufacturable product.
Cosmetic contract manufacturing (CDMO) for aesthetic medicine: feasibility, formulation, transfer, scale-up, manufacturing and documentation support under coordinated technical ownership.
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One continuous technical path
Etternity Dermal
From brief to batch
Projects move through verifiable gates: requirements, prototype, product–container compatibility, scale-up, specifications, manufacturing and release.
We integrate formula, process, components, quality and documentation decisions to reduce late changes and preserve project traceability.
Specialist services
Three areas working as one project
Choose the closest starting point; final scope is confirmed after reviewing formula, format, market and scale.
Stability and packaging compatibility
Product–container stability and compatibility studies designed to anticipate interaction, migration and performance loss.
Regulatory documentation and PIF
Documentation structured around the product information file, safety assessment, claims and target market.
Decision-maker question
Capabilities expressed as verifiable parameters, not promises
What cleanroom filling capabilities does Etternity Dermal offer?
Etternity Dermal operates with an ISO 7 classified cleanroom (Class C at rest) under ISO 14644-1, terminal HEPA H14 filtration and a staged differential-pressure cascade. The site integrates a sanitary Purified Water (PW) loop and filling capability for 2–50 ml Type I glass vials. Nitrogen inerting is assessed for sensitive formulas as part of process validation. The 1–5 ml Luer-Lock syringe platform is in development; every addition will be qualified, validated and technically accepted before it is presented as an available manufacturing capability.
Capability status: current vial and process systems remain project-dependent; the syringe platform is in development.
- Problem
- Environmental control for critical operations
- Technical parameter
- ISO 7 / Class C at rest; HEPA H14 with nominal 99.995% efficiency at 0.3 µm
- Plant solution
- Classified environment with terminal filtration and monitored pressure cascade.
- Problem
- Process-water quality
- Technical parameter
- PW: conductivity <1.3 µS/cm at 25 °C; TOC <500 ppb; endotoxins <0.25 EU/ml
- Plant solution
- Closed sanitary loop with recirculation and critical-parameter monitoring.
- Problem
- Product compatibility and protection
- Technical parameter
- 2–50 ml Type I vials; N2 sweep up to 99.999% where justified by the project
- Plant solution
- Formula, closure, atmosphere and process are selected together before batch validation.
- Problem
- Precision in future syringe formats
- Technical parameter
- 1–5 ml Luer-Lock; target filling tolerance ±0.5%
- Plant solution
- Platform in development, subject to equipment qualification, validation and product–container compatibility.
Download technical data sheetIndexable PDF · cleanroom classification, PW loop, formats and capability status
Download technical data sheet Etternity Dermal
Define scope before committing time and cost
The evaluator turns your answers into a technical brief for an initial fit review.