Controlled document PF-002A
OAA DUO Phase 2 Master Formula
TemplateDocumented
Record identification
- Document ID
- PF-002A
- Document type
- Template
- Status
- Documented
- Source
- Standardisation & Production of SIRIAM Products
Overview
PF-002A — MASTER PRODUCT FORMULA
OAA DUO — Phase 2
Regenerative Integration
Document Control
Field
Document code
Product code
Formula code
Product name
Anatomical system
Region
Therapeutic phase
Product type
Reference batch
Status
Version
Pharmaceutical review
| Value |
|---|
| SIR-PF-002A |
| OAA-02 |
| MF-002 |
| SIRIAM OAA DUO — Phase 2 |
| Occipito-atlanto-axial |
| C0–C2 |
| Regenerative Integration |
| Topical magistral cream |
| 100 g |
| Master Candidate — pharmaceutical reconciliation required |
| ______ |
| Anouck Van Aerschot |
ValueSIR-PF-002A
ValueOAA-02
ValueMF-002
ValueSIRIAM OAA DUO — Phase 2
ValueOccipito-atlanto-axial
ValueC0–C2
ValueRegenerative Integration
ValueTopical magistral cream
Value100 g
ValueMaster Candidate — pharmaceutical reconciliation required
Value______
ValueAnouck Van Aerschot
1. Master Formula — 100 g
The Phase 2 formula and its exact listed quantities are transcribed from the uploaded fiche.
| Code |
|---|
| Ingredient |
| Master quantity |
| Unit/form |
| Process phase |
| Critical note |
| PC-001 |
| Lanette Cream |
| 68 |
| g |
| Base |
| Current specified mass |
| PC-002 |
| Aqua purificata |
| 16 |
| g |
| Water |
| Heat separately |
| SC-003 |
| D-Panthenol, Natural Heroes |
| 2 |
| g |
| Water/cooling |
| Source protocol dissolves it in water phase |
| AC-006 |
| Niacinamide powder |
| 1.5 |
| g |
| Water |
| Dissolve completely |
| BE-003 |
| Ginkgo biloba, Mattisson |
| 0.7 |
| g |
| Cooling/dispersion |
| Add gradually |
| SC-001 |
| MSM, dry |
| 1.5 |
| g |
| Dispersion |
| Pre-disperse in jojoba |
| AC-004 |
| Coenzyme Q10 |
| 0.5 |
| g |
| Lipid dispersion |
| Pre-disperse in jojoba |
| SC-004 |
| Vitamin E |
| 0.5 |
| g |
| Lipid |
| Include in active dispersion |
| BE-001 |
| Boswellia softgel content |
| 0.5 |
| g |
| Lipid dispersion |
| Plus one Frankincense drop |
| BE-011 |
| Frankincense |
| 1 |
| drop |
| Lipid/cooling |
| Included with Boswellia |
| BE-002 |
| Copaiba |
| 0.3 |
| g |
| Cooling |
| Add below 35°C |
| BE-005 |
| Blue Lotus |
| 1 drop per 300 g |
| drop |
| Cooling |
| Production-scale instruction |
| SC-005 |
| Silicea Gel |
| 3 |
| g |
| Cooling |
| Uniform dispersion required |
| HC-010 |
| Silicea D8 |
| 1 |
| drop |
| Cooling |
| Source says “+ drop”; exact count shown in prior Phase 1 format |
| PR-001 |
| Cosgard 221 |
| 0.7 |
| g |
| Cooling |
| Add below 35–40°C |
| PC-003 |
| Jojoba Oil |
| q.s. |
| processing aid |
| Dispersion |
| Exact quantity not specified |
CodeIngredient
CodeMaster quantity
CodeUnit/form
CodeProcess phase
CodeCritical note
CodePC-001
CodeLanette Cream
Code68
Codeg
CodeBase
CodeCurrent specified mass
CodePC-002
CodeAqua purificata
Code16
Codeg
CodeWater
CodeHeat separately
CodeSC-003
CodeD-Panthenol, Natural Heroes
Code2
Codeg
CodeWater/cooling
CodeSource protocol dissolves it in water phase
CodeAC-006
CodeNiacinamide powder
Code1.5
Codeg
CodeWater
CodeDissolve completely
CodeBE-003
CodeGinkgo biloba, Mattisson
Code0.7
Codeg
CodeCooling/dispersion
CodeAdd gradually
CodeSC-001
CodeMSM, dry
Code1.5
Codeg
CodeDispersion
CodePre-disperse in jojoba
CodeAC-004
CodeCoenzyme Q10
Code0.5
Codeg
CodeLipid dispersion
CodePre-disperse in jojoba
CodeSC-004
CodeVitamin E
Code0.5
Codeg
CodeLipid
CodeInclude in active dispersion
CodeBE-001
CodeBoswellia softgel content
Code0.5
Codeg
CodeLipid dispersion
CodePlus one Frankincense drop
CodeBE-011
CodeFrankincense
Code1
Codedrop
CodeLipid/cooling
CodeIncluded with Boswellia
CodeBE-002
CodeCopaiba
Code0.3
Codeg
CodeCooling
CodeAdd below 35°C
CodeBE-005
CodeBlue Lotus
Code1 drop per 300 g
Codedrop
CodeCooling
CodeProduction-scale instruction
CodeSC-005
CodeSilicea Gel
Code3
Codeg
CodeCooling
CodeUniform dispersion required
CodeHC-010
CodeSilicea D8
Code1
Codedrop
CodeCooling
CodeSource says “+ drop”; exact count shown in prior Phase 1 format
CodePR-001
CodeCosgard 221
Code0.7
Codeg
CodeCooling
CodeAdd below 35–40°C
CodePC-003
CodeJojoba Oil
Codeq.s.
Codeprocessing aid
CodeDispersion
CodeExact quantity not specified
2. Production Workflow
Step
1
2
3
4
5
6
7
8
9
10
11
12
13
14
| Procedure |
|---|
| Initial |
| Verify materials, version and lot numbers |
| ___ |
| Weigh Lanette Cream and Aqua purificata separately |
| ___ |
| Heat both to approximately 60°C |
| ___ |
| Dissolve Niacinamide and D-Panthenol in the aqueous phase |
| ___ |
| Pre-disperse MSM, Q10, Boswellia and Vitamin E using the minimum required jojoba oil |
| ___ |
| Add aqueous phase gradually to the Lanette base |
| ___ |
| Add lipophilic active dispersion around 40°C |
| ___ |
| Add Ginkgo gradually without clumping |
| ___ |
| Cool to below 35°C |
| ___ |
| Add Copaiba, Blue Lotus, Silicea Gel, Silicea D8 and Cosgard |
| ___ |
| Homogenise gently for 1–2 minutes |
| ___ |
| Check pH 5.2–5.5 and viscosity |
| ___ |
| Fill into 15 ml airless dispensers |
| ___ |
| Stabilise for 24 hours |
| ___ |
ProcedureInitial
ProcedureVerify materials, version and lot numbers
Procedure___
ProcedureWeigh Lanette Cream and Aqua purificata separately
Procedure___
ProcedureHeat both to approximately 60°C
Procedure___
ProcedureDissolve Niacinamide and D-Panthenol in the aqueous phase
Procedure___
ProcedurePre-disperse MSM, Q10, Boswellia and Vitamin E using the minimum required jojoba oil
Procedure___
ProcedureAdd aqueous phase gradually to the Lanette base
Procedure___
ProcedureAdd lipophilic active dispersion around 40°C
Procedure___
ProcedureAdd Ginkgo gradually without clumping
Procedure___
ProcedureCool to below 35°C
Procedure___
ProcedureAdd Copaiba, Blue Lotus, Silicea Gel, Silicea D8 and Cosgard
Procedure___
ProcedureHomogenise gently for 1–2 minutes
Procedure___
ProcedureCheck pH 5.2–5.5 and viscosity
Procedure___
ProcedureFill into 15 ml airless dispensers
Procedure___
ProcedureStabilise for 24 hours
Procedure___
3. Quality Control
Parameter
Appearance
Homogeneity
Q10 dispersion
pH
Viscosity
Colour
Odour
Actual yield
Batch released
| Target |
|---|
| Actual |
| Pass |
| Smooth cream |
| ______ |
| □ |
| Uniform, no visible particles |
| ______ |
| □ |
| No visible agglomeration |
| ______ |
| □ |
| 5.2–5.5 |
| ______ |
| □ |
| Airless compatible |
| ______ |
| □ |
| Reference standard |
| ______ |
| □ |
| Reference standard |
| ______ |
| □ |
| Record |
| ______ |
| □ |
| Pharmacist approval |
| ______ |
| □ |
TargetActual
TargetPass
TargetSmooth cream
Target______
Target□
TargetUniform, no visible particles
Target______
Target□
TargetNo visible agglomeration
Target______
Target□
Target5.2–5.5
Target______
Target□
TargetAirless compatible
Target______
Target□
TargetReference standard
Target______
Target□
TargetReference standard
Target______
Target□
TargetRecord
Target______
Target□
TargetPharmacist approval
Target______
Target□
4. Application Protocol
Period
Week 3
Week 4
Week 5
Relapse
| Application |
|---|
| Phase 2 morning; Phase 1 evening |
| Phase 2, 1–2 times daily |
| Phase 2 in the evening |
| Phase 1 for 3 days before returning to Phase 2 |
ApplicationPhase 2 morning; Phase 1 evening
ApplicationPhase 2, 1–2 times daily
ApplicationPhase 2 in the evening
ApplicationPhase 1 for 3 days before returning to Phase 2
5. Pharmaceutical Reconciliation Required
Item
Jojoba Oil
Blue Lotus
Silicea D8
Frankincense
D-Panthenol
Formula mass balance
Packaging yield
| Required decision |
|---|
| Establish exact processing quantity |
| Establish reproducible dilution/stock solution |
| Confirm exact number of drops in Phase 2 |
| Define oil/extract identity, supplier and drop mass |
| Confirm whether addition occurs in warm aqueous phase or below 40°C |
| Listed ingredients total approximately 95.7 g before jojoba, Blue Lotus, Frankincense and Silicea D8; define Lanette q.s. ad 100 g or revise Aqua/Lanette amounts |
| Determine expected number of 15 ml dispensers by actual density and process loss |
Required decisionEstablish exact processing quantity
Required decisionEstablish reproducible dilution/stock solution
Required decisionConfirm exact number of drops in Phase 2
Required decisionDefine oil/extract identity, supplier and drop mass
Required decisionConfirm whether addition occurs in warm aqueous phase or below 40°C
Required decisionListed ingredients total approximately 95.7 g before jojoba, Blue Lotus, Frankincense and Silicea D8; define Lanette q.s. ad 100 g or revise Aqua/Lanette amounts
Required decisionDetermine expected number of 15 ml dispensers by actual density and process loss
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