One traceable development pathway—from source to scientifically qualified material.
Eleven proposed stations in work order, with custody recorded at every hand-off and partner work sent and returned sealed.
Status. Nothing here exists yet: no site, equipment or partner agreement. The drawings explain a proposed arrangement, not a real building.
How to read the proposed journey
- Every station is labeled with its proposed phase or as partner work.
- Custody first and last: receiving, sampling and release frame every journey.
- Select a room in either drawing to open the page on that work.
Rooms are arranged in the order a sample would meet them, with partner work off site
The plan is wider than this screen: scroll sideways, or use the station list below.
Select a station, or follow one sample
Each numbered room is one step in qualifying a botanical ingredient. Select a room, or use the station list below the drawing.
Samples, results and decisions remain traceable across qualified internal and external partners.
Explanation, details and sources
Why it mattersSplit across vendors without a shared record, evidence scatters and decisions come late. One record per lot, covering in-house and partner work, is meant to shorten that loop.
Eleven stations and the off-site partners, in the order a sample meets them
A plan view of the same rooms shows where the sample changes hands; the board shows which phase would bring each piece of equipment.
- 1 Receiving and custody
- 2 Identity
- 3 Analytical
- 4 Extraction
- 5 Separation
- 6 Formulation
- 7 Drying
- 8 Stability
- 9 Microbiology
- 10 Release and data
- 11 Pilot packaging and scale-up
Station list: what each station does, its equipment, its result and the rules that apply (with "Show on drawing")
Receiving, quarantine and sampling
Phase I · provisional Bulk milling · Phase II · provisional
Each incoming lot is checked against its paperwork, given a unique ID, held in quarantine and sampled to an approved sampling plan. Part of each sample is retained.
- Equipment
- Receiving bench and quarantine racks with status labels Phase I · prov.
- Sampling booth with dust extraction Phase I · prov.
- Hammer mill and sieves for bulk milling Phase II · prov.
- Result
- A logged, quarantined lot with representative samples, and a custody record that every later result points back to.
- Rules
- 21 CFR 111.155 (receipt, quarantine); 21 CFR 111.80 (representative samples).
Identity lab
Phase I DNA barcoding · partner
Confirms the plant is the right species and plant part before any other work starts.
- Equipment
- Microscopes Phase I
- HPTLC fingerprinting and documentation Phase I
- Reference specimen cabinet Phase I
- DNA barcoding External partner
- Result
- An identity decision for every lot. The rule requires at least one identity test of each dietary-ingredient lot (21 CFR 111.75(a)(1)(i)); the plan uses two independent methods.
Analytical lab
Phase I Second LC-MS · Phase II NMR · partner
Measures what is in the material: marker compounds, adulterants, metals, pesticides and residual solvents.
- Equipment
- HPLC and UHPLC stacks, sample preparation Phase I
- LC-MS/MS and high-resolution LC-MS Phase I
- GC-MS; ICP-MS for elemental impurities Phase I
- Second LC-MS Phase II
- NMR External partner
- Result
- Composition and contaminant results, compared with specifications.
- Floor area
- Analytical chemistry and QC, 7,000 sq ft in the proposed full-build area program.
Extraction bay
Lab scale · Phase I Pilot · Phase II
Pulls the active compounds out of the plant with ethanol–water or supercritical CO₂.
- Equipment
- Laboratory supercritical CO₂ extraction and CO₂ supply Phase I
- Rotary evaporator and balances Phase I
- Pilot percolation vessels Phase II
- Ultrasound-assisted extraction bench Not yet assigned
- Result
- A crude extract with measured yield and composition, reported separately: a high yield is not a high purity.
- Floor area
- Discovery and extraction labs, 5,000 sq ft; pilot plant, 10,000 sq ft (proposed area program).
Separation and concentration
Lab scale · Phase I Pilot equipment · Phase II
Removes the solvent for reuse, then concentrates or purifies the extract. Laboratory-scale concentration uses the extraction bay's rotary evaporator.
- Equipment
- Falling-film evaporator with condenser Phase II
- Solvent receiver for recovery Phase II
- Adsorption-resin columns Not yet assigned
- Membrane filtration skid Not yet assigned
- Result
- A concentrated extract, and recovered solvent returned to extraction.
Formulation and nanoemulsion
Phase I Pilot vessels · Phase II
Turns the extract into a stable, dosable form: emulsions, dispersions and encapsulates.
- Equipment
- High-pressure homogenizer Phase I
- Droplet sizing by dynamic light scattering and laser diffraction Phase I
- Jacketed mixing vessels Pilot scale · Phase II
- Result
- Formulations with measured droplet size and physical stability. Neither is evidence of absorption in people.
- Floor area
- Formulation R&D, 5,000 sq ft (proposed area program).
Drying
Lab · Phase I Pilot · Phase II Commercial · Phase III
Turns a liquid into a stable powder without overheating the actives.
- Equipment
- Laboratory spray dryer and freeze-dryer Phase I
- Pilot spray dryer with cyclone and bag filter; pilot freeze-dryer; fluid-bed dryer Phase II
- Commercial-scale dryer (not drawn) Phase III
- Result
- Free-flowing powder with measured moisture, ready for blending.
Stability chambers
Phase I Walk-in chamber · Phase II
Stores samples at set temperature and humidity to see how long they stay within specification.
- Equipment
- Reach-in chambers with continuous temperature and humidity logging Phase I
- Walk-in stability chamber Phase II
- Result
- Stability data, the evidence needed before a shelf life can be set. Accelerated data alone do not validate a shelf life.
- Floor area
- Shares microbiology, stability and QA, 6,000 sq ft (proposed area program).
Microbiology
Phase I
Tests materials and products for microorganisms and compares results with microbial limits, in a separated suite.
- Equipment
- Biological safety cabinet, incubators, autoclave, plate-counting bench Phase I
- Compendial methods, USP <2021>–<2023> Phase I
- Result
- Microbial results for every lot before release.
Quality release and data
Phase I
Quality control reviews every record and releases or rejects each lot. All results, including partner results, land in one data system. Retained and reserve samples are stored here.
- Equipment
- Record-review stations; LIMS and electronic notebooks Phase I
- Retained and reserve sample storage Phase I
- Result
- A release decision and one complete record per lot. Quality control makes disposition decisions (21 CFR 111.87); reserve samples of packaged supplements are kept as 21 CFR 111.83 requires.
Pilot packaging
Phase II Phase III
Blends released material and fills it into capsules or powders, then packs it.
- Equipment
- Bin blender, capsule filler, packaging conveyor Phase II–III
- Result
- Packed, labeled product from released lots only.
- Floor area
- Packaging, 7,000 sq ft (proposed area program, Phase III).
Qualified external partners, off site
External partner
Work outside the planned in-house scope would go to qualified partners: DNA barcoding, NMR, toxicology studies, human studies, plasma bioanalysis and, until Phase III, commercial-scale manufacturing.
- Partners
- Accredited testing laboratories (scope checked per test) Partner
- Toxicology CROs, GLP where appropriate Partner
- Clinical research organizations and bioanalytical laboratories Partner
- Contract manufacturers Partner
- Result
- Partner results return to the same lot record and are reviewed by EUTECNIQ quality before use. No partner agreement is signed.
Twelve steps from the receiving dock to a released lot, with custody kept at every hand-off
The rules cited are legal minimums for dietary-supplement manufacturing; the rest is proposed practice. "Follow one sample" walks the drawing through the same steps.
Text version of the twelve steps
- Receive and logContainers are checked for damage and broken seals, paperwork is checked against the purchase order, and the lot gets a unique ID that every later record uses (21 CFR 111.155(a)–(b)).
- QuarantineThe lot is held under quarantine status, physically and in the records, until quality control approves it for use (21 CFR 111.155(c)).
- Sample and retainRepresentative samples are drawn to a sampling plan approved by quality control (21 CFR 111.80(a), 111.315(b)). One portion goes to testing; another is sealed, labeled and retained for investigations.
- Confirm identityMicroscopy and HPTLC confirm species and plant part against authenticated references. A wrong plant stops here.
- Measure compositionChromatography and mass spectrometry measure markers, adulterants, metals, pesticides and residual solvents.
- Send specialist tests outTests outside the planned scope, such as DNA barcoding or NMR, go to qualified partners. Samples travel sealed with a chain-of-custody form; results return to the same lot record.
- Approve or reject the lotQuality control reviews all results and approves the lot for use or rejects it (21 CFR 111.155(c)). Only then does it leave quarantine.
- Mill and extractAt pilot scale, approved material is milled to a set particle size (Phase II, provisional), then extracted with ethanol–water or supercritical CO₂.
- Concentrate and purifyThe solvent is evaporated and recovered for reuse; resins or membranes may clean up the extract.
- Formulate and dryThe extract becomes an emulsion or dispersion with a measured droplet size, then a stable powder.
- Prove stability and microbial qualitySamples go into stability chambers and through microbiology testing against limits.
- Release, retain and packQuality control reviews the complete record and releases or rejects the lot (21 CFR 111.87). Reserve samples are kept as the rule requires (21 CFR 111.83). Only released material is packed.
Custody would be recorded at every hand-off, inside the building and across partner sites
Text version of the custody record and the partner hand-off
What would be recorded for every sample
- A unique ID linked to the parent lot, supplier and purchase order.
- Each transfer: who released it, who received it, date, time and location.
- Condition on receipt, seal numbers and storage conditions.
- Tests requested, the laboratory and the method version used.
- Retention location, retention period and final disposal.
When a sample goes to a partner
- A signed chain-of-custody form travels with the sample in a sealed, tamper-evident container.
- A temperature record travels with materials that need it.
- The partner confirms receipt and condition; its scope of accreditation or study status is checked for that test.
- Results return to the lot record and are reviewed by EUTECNIQ quality before any decision uses them.
Sources: eCFR, 21 CFR 111.80, 111.83, 111.155, 111.465, 111.605, current to Oct 21, 2026; ANAB, "ISO/IEC 17025:2017 process requirements" (summary of clause 7.4). Retained samples of incoming components are proposed practice, not a Part 111 requirement.
Explanation, details and sources
Chain of custody is the unbroken record of who held a sample, when, where and in what condition. It lets a result be trusted when the work is split between EUTECNIQ and its partners.
| Requirement or standard | What it requires | Applies to |
|---|---|---|
| 21 CFR 111.155 Regulatory requirement | Examine containers and paperwork on receipt; quarantine components until representative samples are collected and quality control approves them. | Components of dietary supplements |
| 21 CFR 111.80 Regulatory requirement | Collect representative samples of each unique lot of components, packaging and labels, and of each unique shipment. | Dietary-supplement manufacturing |
| 21 CFR 111.83 and 111.465 Regulatory requirement | Hold reserve samples of each lot of packaged and labeled supplement in the distributed container-closure system, for 1 year past the shelf-life date or 2 years from distribution of the last batch. | Packaged and labeled dietary supplements |
| 21 CFR 111.605 Regulatory requirement | Keep required records for the same period; electronic records must meet 21 CFR Part 11. | Records required by Part 111 |
| ISO/IEC 17025:2017, clause 7.4 Planned accreditation | A procedure for transport, receipt, handling, protection, storage, retention and disposal or return of test items, with a system for identifying them. | An accredited laboratory's scope; EUTECNIQ holds no accreditation |
See how the gates decide what moves on
The platform page sets out each stage's objective, gate and failure modes; the quality system page sets out the rules that would govern release.