Controlled document PF-001A
OAA DUO Phase 1 Master Formula
TemplateDocumented
Record identification
- Document ID
- PF-001A
- Document type
- Template
- Status
- Documented
- Source
- Standardisation & Production of SIRIAM Products
Overview
PF-001A — MASTER PRODUCT FORMULA
OAA DUO — Phase 1
Neuro-Afferent Dampening
Document Control
Field
Document code
Product code
Formula code
Product name
Anatomical system
Region
Therapeutic phase
Product type
Reference batch
Current source
Status
Prepared by
Pharmaceutical review
Version
Effective date
The source formula defines Phase 1 as afferent dampening of the OAA region, followed by regenerative integration in Phase 2.
| Value |
|---|
| SIR-PF-001A |
| OAA-01 |
| MF-001 |
| SIRIAM OAA DUO — Phase 1 |
| Occipito-atlanto-axial |
| C0–C2 |
| Neuro-Afferent Dampening |
| Topical magistral cream |
| 100 g |
| OAA DUO D&R — EMG-Strong |
| Master Candidate — pharmaceutical reconciliation required |
| MT DO, DCP |
| Anouck Van Aerschot |
| ______ |
| ______ |
ValueSIR-PF-001A
ValueOAA-01
ValueMF-001
ValueSIRIAM OAA DUO — Phase 1
ValueOccipito-atlanto-axial
ValueC0–C2
ValueNeuro-Afferent Dampening
ValueTopical magistral cream
Value100 g
ValueOAA DUO D&R — EMG-Strong
ValueMaster Candidate — pharmaceutical reconciliation required
ValueMT DO, DCP
ValueAnouck Van Aerschot
Value______
Value______
1. Product Purpose
Field
Biological objective
Primary phase objective
Anatomical target
Default application
Default phase duration
| Defined value |
|---|
| Support neurodermal modulation of the OAA region |
| Afferent dampening |
| C0–C2 and associated cranio-cervical application zones |
| Thin topical layer, 1–2 times daily |
| Weeks 1–2 |
Defined valueSupport neurodermal modulation of the OAA region
Defined valueAfferent dampening
Defined valueC0–C2 and associated cranio-cervical application zones
Defined valueThin topical layer, 1–2 times daily
Defined valueWeeks 1–2
2. Master Formula — 100 g
Exact quantities and supplier references above are transcribed from the uploaded Phase 1 formula.
| Code |
|---|
| Ingredient |
| Master quantity |
| Unit/form |
| Process phase |
| Critical note |
| PC-001 |
| Lanette Cream |
| 66 |
| g |
| Base |
| Supplement if necessary after incorporation |
| PC-002 |
| Aqua purificata |
| 18 |
| g |
| Water |
| Heat separately to ±60°C |
| SC-002 |
| Magnesium Chloride |
| 4 |
| g |
| Water |
| Source notes irritation above 5% |
| SC-001 |
| MSM |
| 2.5 |
| g |
| Dispersion |
| Pre-disperse in a small amount of jojoba |
| AC-001 |
| Palmitoylethanolamide (PEA), Vitals |
| 2 |
| g / 5 capsules |
| Dispersion |
| Pre-disperse in jojoba; source notes saturation above 3% |
| BE-003 |
| Ginkgo biloba, Mattisson |
| 1 |
| g / 8 capsules |
| Cooling/dispersion |
| Add gradually, avoid clumps |
| BE-001 |
| Boswellia serrata, WeightWorld |
| 2 softgels |
| softgels |
| Lipid dispersion |
| Exact extracted mass not stated |
| BE-002 |
| Copaiba, Aroma-Zone |
| 0.3 |
| ml |
| Cooling |
| Add below 35°C |
| BE-005 |
| Blue Lotus |
| 1 drop per 300 g |
| drop |
| Cooling |
| Equivalent to one-third drop per 100 g; use production-scale instruction |
| BE-007 |
| Melissa officinalis, Soria Natural |
| 1 |
| ml |
| Cooling |
| Thermolabile botanical component |
| HC-001 |
| Gelsemium sempervirens 30C, HEEL |
| 0.5 |
| ml |
| Cooling |
| Source later calls it Gelsemium Homaccord; verify exact product |
| SC-005 |
| Silicea Gel |
| 5 |
| g |
| Cooling / aqueous dispersion |
| Source identifies it as predominantly aqueous |
| HC-010 |
| Silicea D8 |
| 1 |
| drop |
| Cooling |
| Added to Silicea Gel |
| PR-001 |
| Cosgard 221 |
| 0.7 |
| g |
| Cooling |
| Add below 35–40°C |
| PC-003 |
| Jojoba Oil |
| q.s. |
| processing aid |
| Dispersion |
| Quantity is not specified in the source fiche |
CodeIngredient
CodeMaster quantity
CodeUnit/form
CodeProcess phase
CodeCritical note
CodePC-001
CodeLanette Cream
Code66
Codeg
CodeBase
CodeSupplement if necessary after incorporation
CodePC-002
CodeAqua purificata
Code18
Codeg
CodeWater
CodeHeat separately to ±60°C
CodeSC-002
CodeMagnesium Chloride
Code4
Codeg
CodeWater
CodeSource notes irritation above 5%
CodeSC-001
CodeMSM
Code2.5
Codeg
CodeDispersion
CodePre-disperse in a small amount of jojoba
CodeAC-001
CodePalmitoylethanolamide (PEA), Vitals
Code2
Codeg / 5 capsules
CodeDispersion
CodePre-disperse in jojoba; source notes saturation above 3%
CodeBE-003
CodeGinkgo biloba, Mattisson
Code1
Codeg / 8 capsules
CodeCooling/dispersion
CodeAdd gradually, avoid clumps
CodeBE-001
CodeBoswellia serrata, WeightWorld
Code2 softgels
Codesoftgels
CodeLipid dispersion
CodeExact extracted mass not stated
CodeBE-002
CodeCopaiba, Aroma-Zone
Code0.3
Codeml
CodeCooling
CodeAdd below 35°C
CodeBE-005
CodeBlue Lotus
Code1 drop per 300 g
Codedrop
CodeCooling
CodeEquivalent to one-third drop per 100 g; use production-scale instruction
CodeBE-007
CodeMelissa officinalis, Soria Natural
Code1
Codeml
CodeCooling
CodeThermolabile botanical component
CodeHC-001
CodeGelsemium sempervirens 30C, HEEL
Code0.5
Codeml
CodeCooling
CodeSource later calls it Gelsemium Homaccord; verify exact product
CodeSC-005
CodeSilicea Gel
Code5
Codeg
CodeCooling / aqueous dispersion
CodeSource identifies it as predominantly aqueous
CodeHC-010
CodeSilicea D8
Code1
Codedrop
CodeCooling
CodeAdded to Silicea Gel
CodePR-001
CodeCosgard 221
Code0.7
Codeg
CodeCooling
CodeAdd below 35–40°C
CodePC-003
CodeJojoba Oil
Codeq.s.
Codeprocessing aid
CodeDispersion
CodeQuantity is not specified in the source fiche
3. Production Workflow
Step
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
The manufacturing fiche specifies approximately 60°C for the base phases, addition of the active dispersion around 40°C, sensitive ingredients below 35°C and a final pH target of 5.2–5.5.
| Procedure |
|---|
| Initial |
| Verify formula version, materials, supplier products and lot numbers |
| ___ |
| Weigh Lanette Cream and Aqua purificata separately |
| ___ |
| Heat both phases to approximately 60°C |
| ___ |
| Dissolve Magnesium Chloride completely in the aqueous phase |
| ___ |
| Pre-disperse MSM and PEA separately in the minimum required quantity of jojoba oil |
| ___ |
| Open and incorporate the specified Boswellia softgels into the lipophilic dispersion |
| ___ |
| Add the warm aqueous phase gradually to the Lanette base while mixing homogeneously |
| ___ |
| Add the jojoba-active dispersion at approximately 40°C |
| ___ |
| Add Ginkgo gradually and disperse without clumping |
| ___ |
| Cool to below 35°C |
| ___ |
| Add Copaiba, Melissa, Blue Lotus, Gelsemium, Silicea Gel, Silicea D8 and Cosgard |
| ___ |
| Homogenise gently for 1–2 minutes without excessive air incorporation |
| ___ |
| Check pH, viscosity and homogeneity |
| ___ |
| Fill into 15 ml airless dispensers |
| ___ |
| Allow to stabilise for 24 hours before release |
| ___ |
ProcedureInitial
ProcedureVerify formula version, materials, supplier products and lot numbers
Procedure___
ProcedureWeigh Lanette Cream and Aqua purificata separately
Procedure___
ProcedureHeat both phases to approximately 60°C
Procedure___
ProcedureDissolve Magnesium Chloride completely in the aqueous phase
Procedure___
ProcedurePre-disperse MSM and PEA separately in the minimum required quantity of jojoba oil
Procedure___
ProcedureOpen and incorporate the specified Boswellia softgels into the lipophilic dispersion
Procedure___
ProcedureAdd the warm aqueous phase gradually to the Lanette base while mixing homogeneously
Procedure___
ProcedureAdd the jojoba-active dispersion at approximately 40°C
Procedure___
ProcedureAdd Ginkgo gradually and disperse without clumping
Procedure___
ProcedureCool to below 35°C
Procedure___
ProcedureAdd Copaiba, Melissa, Blue Lotus, Gelsemium, Silicea Gel, Silicea D8 and Cosgard
Procedure___
ProcedureHomogenise gently for 1–2 minutes without excessive air incorporation
Procedure___
ProcedureCheck pH, viscosity and homogeneity
Procedure___
ProcedureFill into 15 ml airless dispensers
Procedure___
ProcedureAllow to stabilise for 24 hours before release
Procedure___
4. Critical Process Controls
Control point
PEA/MSM dispersion
Emulsion
Maximum temperature
pH
Viscosity
Air incorporation
Final fill
The original fiche specifically highlights absence of PEA/MSM clumps, homogeneous texture, avoidance of overheating and airless-compatible viscosity.
| Acceptance criterion |
|---|
| Pass |
| No visible clumps or granularity |
| □ |
| Homogeneous; no phase separation |
| □ |
| No overheating above 70°C |
| □ |
| 5.2–5.5 |
| □ |
| Compatible with 15 ml airless dispenser |
| □ |
| Minimal/no visible air pockets |
| □ |
| Uniform dispensing |
| □ |
Acceptance criterionPass
Acceptance criterionNo visible clumps or granularity
Acceptance criterion□
Acceptance criterionHomogeneous; no phase separation
Acceptance criterion□
Acceptance criterionNo overheating above 70°C
Acceptance criterion□
Acceptance criterion5.2–5.5
Acceptance criterion□
Acceptance criterionCompatible with 15 ml airless dispenser
Acceptance criterion□
Acceptance criterionMinimal/no visible air pockets
Acceptance criterion□
Acceptance criterionUniform dispensing
Acceptance criterion□
5. Quality Control & Batch Release
Parameter
Appearance
Colour
Odour
Homogeneity
pH
Viscosity
Theoretical yield
Actual yield
Number of 15 ml dispensers
Label/version correct
Batch released
| Target |
|---|
| Actual |
| Pass |
| Smooth cream |
| ______ |
| □ |
| Batch reference |
| ______ |
| □ |
| Characteristic, no abnormal odour |
| ______ |
| □ |
| Uniform |
| ______ |
| □ |
| 5.2–5.5 |
| ______ |
| □ |
| Airless compatible |
| ______ |
| □ |
| 100 g |
| ______ |
| □ |
| Record |
| ______ |
| □ |
| Approx. 6, depending on density/yield |
| ______ |
| □ |
| Yes |
| ______ |
| □ |
| Pharmacist approval |
| ______ |
| □ |
TargetActual
TargetPass
TargetSmooth cream
Target______
Target□
TargetBatch reference
Target______
Target□
TargetCharacteristic, no abnormal odour
Target______
Target□
TargetUniform
Target______
Target□
Target5.2–5.5
Target______
Target□
TargetAirless compatible
Target______
Target□
Target100 g
Target______
Target□
TargetRecord
Target______
Target□
TargetApprox. 6, depending on density/yield
Target______
Target□
TargetYes
Target______
Target□
TargetPharmacist approval
Target______
Target□
6. Application Protocol
Period
Weeks 1–2
Week 3
Relapse
Application zones in the source fiche are: preauricular/anterior to the ear, mandibular, temporal and retroauricular. The broader OAA application protocol already developed in the handbook can later add the definitive suboccipital and pre-SCM nomenclature once formally reconciled with the product label.
| Application |
|---|
| OAA Phase 1, 1–2 times daily |
| OAA Phase 2 morning; OAA Phase 1 evening |
| Reintroduce Phase 1 for 3 days |
ApplicationOAA Phase 1, 1–2 times daily
ApplicationOAA Phase 2 morning; OAA Phase 1 evening
ApplicationReintroduce Phase 1 for 3 days
7. Pharmaceutical Reconciliation Required
Before assigning LOCKED status, Anouck should review these source ambiguities:
Item
Boswellia
Jojoba Oil
Blue Lotus
Gelsemium
Lanette adjustment
Yield wording
Preservation
Formula sum
| Required decision |
|---|
| Convert “2 softgels” into exact incorporated mass and record the capsule strength |
| Define exact quantity or explicitly designate it as processing aid q.s. |
| Define a reproducible preparation instruction for 100 g batches; one-third drop is not directly measurable |
| Confirm whether the actual product is a single 30C dilution or Gelsemium Homaccord |
| Replace “supplement if insufficient” with a controlled q.s. instruction based on final mass |
| Formula states 100 g but also refers to 100 ml and six 15 ml containers; standardise by mass and measured yield |
| Confirm Cosgard 221 supplier specification and final authorised concentration |
| Final mass cannot be confirmed exactly until the softgel and jojoba quantities are standardised |
Required decisionConvert “2 softgels” into exact incorporated mass and record the capsule strength
Required decisionDefine exact quantity or explicitly designate it as processing aid q.s.
Required decisionDefine a reproducible preparation instruction for 100 g batches; one-third drop is not directly measurable
Required decisionConfirm whether the actual product is a single 30C dilution or Gelsemium Homaccord
Required decisionReplace “supplement if insufficient” with a controlled q.s. instruction based on final mass
Required decisionFormula states 100 g but also refers to 100 ml and six 15 ml containers; standardise by mass and measured yield
Required decisionConfirm Cosgard 221 supplier specification and final authorised concentration
Required decisionFinal mass cannot be confirmed exactly until the softgel and jojoba quantities are standardised
Related documents
Platform modules