Controlled document PF-003A
PHRENIC DUO Phase 1 Master Formula
Record identification
- Document ID
- PF-003A
- Document type
- Template
- Status
- Documented
- Source
- Standardisation & Production of SIRIAM Products
Overview
PF-003A
PRODUCT FORMULA CARD
SIRIAM PHRENIC DUO – PHASE 1 (RELEASE)
DOCUMENT CONTROL
Field
Product ID
Formula ID
Document
Product
Anatomical Region
Therapeutic Phase
Product Type
Standard Batch
Version
Status
Internal QR
The source fiche defines Phase 1 as the release formulation for neurodermal modulation of the phrenico-cervical axis (C3–C5).
| Value |
|---|
| SIR-PHR-001 |
| MF-003 |
| PF-003A |
| PHRENIC DUO – Phase 1 |
| C3–C5 |
| Release |
| Topical Magistral Cream |
| 100 g |
| 2.0 |
| 🔒 LOCKED |
| ☐ |
1. PRODUCT PURPOSE
Field
Clinical Objective
Anatomical Region
Biological Target
Product Type
| Description |
|---|
| Neurodermal modulation of the phrenico-cervical axis |
| C3–C5 |
| Cervical decompression and afferent unloading |
| Topical Magistral Cream |
2. MASTER FORMULA
All quantities are transcribed directly from the uploaded magistral fiche.
| Code |
|---|
| Ingredient |
| Master Qty |
| Unit |
| Phase |
| PC-001 |
| Lanette Cream |
| 65.00 |
| g |
| B |
| PC-002 |
| Aqua Purificata |
| 18.00 |
| g |
| W |
| SC-002 |
| Magnesium Chloride |
| 4.00 |
| g |
| W |
| SC-001 |
| MSM |
| 2.50 |
| g |
| W |
| SC-003 |
| D-Panthenol |
| 1.00 |
| g |
| W |
| SC-004 |
| Vitamin E |
| 0.50 |
| g |
| D |
| BE-009 |
| Arnica Oil |
| 2.00 |
| g |
| C |
| BE-008 |
| Ruta graveolens |
| 1.20 |
| mL |
| C |
| BE-010 |
| Hypericum D8 |
| 1.00 |
| mL |
| C |
| HC-002 |
| Chelidonium majus |
| 0.30 |
| mL |
| C |
| BE-002 |
| Copaiba Oil |
| 0.50 |
| g |
| C |
| SC-005 |
| Silicea Gel |
| 1.00 |
| mL |
| C |
| HC-010 |
| Silicea D8 |
| 1 drop |
| — |
| C |
| AC-005 |
| Taurine |
| 0.80 |
| g |
| W |
| AC-001 |
| Palmitoylethanolamide (PEA) |
| 1.20 |
| g |
| D |
| HC-006 |
| Aesculus compositum (HEEL) |
| 0.50 |
| mL |
| C |
| PR-001 |
| Cosgard |
| 0.70 |
| mL |
| C |
3. MANUFACTURING WORKFLOW
The manufacturing sequence follows the Lanette protocol in the source document.
- Equipment verification
- Water phase
- Prepare PEA/Vitamin E dispersion
- Emulsification
- Add botanical components
- Cooling (<35°C)
- Add Silicea components
- Final homogenisation
- Filling
- Packaging
- Quality Control
- Batch Release
4. QUALITY CONTROL
Parameter
Appearance
Colour
Odour
Homogeneity
pH
Viscosity
Fill Weight
The fiche specifies a target pH of 5.2–5.5, filling into airless dispensers and a 24-hour stabilisation period.
| Target |
|---|
| Result |
| Standard |
| Standard |
| Standard |
| Pass |
| 5.2–5.5 |
| Airless compatible |
| Standard |
5. BATCH RELEASE
Field
Batch Number
Production Date
Yield
Prepared by
Checked by
Released by
| Value |
|---|
6. CLINICAL APPLICATION
Field
Anatomical Region
Application Zones
Frequency
Treatment Phase
Application zones and treatment protocol are specified in the source fiche.
| Value |
|---|
| C3–C5 |
| Paravertebral C3–C5, supraclavicular, shoulder region |
| 1–2× daily |
| Weeks 1–2 |
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