V5 Ultimate
Modern industrial plastics compounding plant interior with a stainless steel twin-screw extruder producing white polymer pellets through a die head into a water bath and pelletizer, gowned technicians in navy coveralls and safety glasses under bright industrial lighting
Connected MES + QMS + LIMS + auto Certificate of Compliance

From virgin pellet & masterbatch to sealed customer gaylord — one Certificate of Compliance in your customer's format — recipe, regrind ratio and substance status locked.

V5 Ultimate runs every step your medical-device, food-contact and automotive customers audit — Approved Supplier + REACH / RoHS qualification, barcode-scanned receipt of every super-sack and gaylord, gravimetric dispense of virgin resin, color masterbatch and additives against the locked recipe, extruder / MFI capture, regrind ratio tracked shot-by-shot, physical / rheological / thermal testing in the LIMS, per-customer specs, REACH SVHC and RoHS status by lot, and an auto-generated Certificate of Compliance in your customer's format at bag-off. No paper travelers, no regrind guesswork, no customer incoming-QA rejection.

Built for ISO 9001, IATF 16949, FDA 21 CFR 177 (food contact), and USP Class VI.

One thread, virgin resin & masterbatch to sealed customer gaylord
step 01
Supplier & receive
CoA · REACH · RoHS
step 02
Dispense
Gravimetric · to the gram
step 03
Extrude & pelletize
MFI · regrind live
step 04
LIMS & release
MFI · tensile · 2-sig
step 05
Bag-off & label
Auto customer CoC
step 06
Dispatch
Customer · molder · trace
One system, three lenses

The same batch record — seen the way you run the plant.

For a compounder or molder supplying regulated end-markets, the small wins compound with every gaylord. Finance sees higher first-pass yield and regrind used to spec. Operations sees the next grade changeover clear the purge check on time. Quality sees a Certificate of Compliance the customer's incoming-QA and their regulator will accept without a phone call.

The CFO view

Higher first-pass yield on premium virgin resin and masterbatch — dispense drift squeezed, giveaway killed, regrind used to spec, and true cost per kg finally on the page.

  • Per-lot actual cost: virgin resin, masterbatch, additives, packaging, regrind, labour and rework — visible in $, today.
  • Lower giveaway from gravimetric dispense and MFI monitoring — no over-add of expensive masterbatch or additive.
  • Fewer customer incoming-QA rejections from CoC transcription errors, wrong-substance-status entries and spec-column drift.
  • Most compounders and molders see V5 pay back inside year one and keep compounding.
Lot yield · todaylive
PP med Class VI
+4.4 pts
PE food-contact
+3.2 pts
PC/ABS auto grade
+2.8 pts
PP glass-filled
+4.1 pts
TPE soft-touch
+2.0 pts
Masterbatch over-add killed7-day
+$48,720
Dispense drift falling ↓
Cost per 25-kg bag · today
$34.85 / bag
Virgin resin 62% Masterbatch 14% Labour 14% QC 10%
+11 pts
First-pass yield uplift
Recipe lockdown, gravimetric dispense and MFI monitoring catch drift at the feeder, not final release.
−48%
Lot review-and-release cycle
Self-building lot record and auto customer-CoC — no evenings retyping results into an Excel template.
Daily
True cost per kg produced
Actual virgin resin, masterbatch, additive, packaging and labour cost posted from each lot — not month-end reconciliation.
0
Customer CoA rejections from transcription
Results flow from released blend data into the customer's template — no manual typing.
Walk the process

From the qualified virgin & masterbatch lot to the sealed customer gaylord & Certificate of Compliance — one recipe-locked thread.

Follow one compound lot. Every step below is a single screen in V5 — and the approved-supplier program, REACH SVHC / RoHS status, food-contact / USP Class VI evidence and customer-specific spec library run underneath them all.

Step 01 · Approved supplier, REACH / RoHS & receiving

Qualified supplier, verified virgin & masterbatch lot, substance status intact — before a pellet reaches the extruder throat.

Every virgin resin, color masterbatch, additive, filler and regrind lot is tied to a qualified supplier with a live supplier CoA, REACH SVHC declaration, RoHS statement and — where food-contact or medical grade — a 21 CFR 177 or USP Class VI statement. Super-sacks, totes, gaylords and 25-kg bags are barcode-scanned at goods-in, sampled per plan, and their substance status (SVHC, RoHS, food-contact, USP VI) is carried lot-by-lot into segregated stores. A missing CoA, an expired REACH declaration or a broken substance chain rejects the pallet at the dock — not after it's dumped into the extruder throat.
Plastic resin receiving dock with a warehouse operator in safety vest and hard hat scanning a barcode label on a stack of 25-kg kraft bags and gaylord boxes of virgin polymer pellets and color masterbatch
Step 02 · Gravimetric dispense, extrusion & MFI / regrind uniformity

The only recipe the line can run is the released, customer-approved version — drift from the recipe or regrind ratio is physically impossible.

The approved master batch recipe snapshots into every work order — immutable, rev-locked and pinned to the current customer spec. Loss-in-weight feeders and gravimetric dispense verify each minor and micro ingredient to the gram. Extruder screw speed, barrel temperature, torque, melt temperature and pressure stream to the batch record. Regrind ratio is captured shot-by-shot and enforced against the customer spec. A recipe change routes through QA and — where the customer's Certificate of Compliance is affected — the customer's approval before a new rev reaches the line.
+11 pts
first-pass yield with recipe lockdown & shot-level regrind control
−48%
lot release cycle vs Excel + email CoC workflow
Plastics twin-screw compounding extruder with molten polymer strands exiting the die into a water bath, operator at a touchscreen HMI adjusting screw speed
Step 03 · MFI, tensile, thermal & substance assay

The batch can't ship until every customer-spec attribute is green — and the reviewer sees every OOS in one place.

V5 runs a full polymer LIMS in the same tenant — melt flow index (MFI / MVR), tensile (yield, break, elongation), flexural modulus, Izod impact, DSC / TGA thermal, density, moisture (Karl Fischer), colour (L*a*b* / ΔE), FTIR resin identity, heavy metals (ICP-MS), REACH SVHC screen (LC-MS/MS), RoHS elements, migration (for food-contact) and USP Class VI biological reactivity. Any OOS opens an investigation and blocks the next operation. Two-signature release — production and QA — closes the batch record before dispatch.
Polymer QC technician in white lab coat and safety glasses at a lab bench with a melt flow indexer, tensile tester, FTIR spectrometer and small clear sample jars of plastic pellets labeled with lot codes
Step 04 · Bag-off, checkweigh & auto Certificate of Compliance

One finished compound lot, one CoC in the customer's format, one QA-signed unit — no manual retyping into the customer's CoC template.

Every 25-kg bag, octabin, gaylord and super-sack is filled by net-weight, checkweighed, metal-detected and labelled with the current-rev bag label — grade, lot code, MFI, colour ref and customer-specific artwork. At bag-off, V5 populates the customer's CoC template from the released lot data — customer's spec limits, methods, columns, substance status (REACH SVHC, RoHS, 21 CFR 177, USP Class VI) and header — and dispatches it with the shipment. No transcription errors, no version drift, no customer incoming-QA rejection because a spec column moved.
Plastic pellet bagging line filling a 25-kg poly-lined bag of resin pellets on a checkweigher with a print-and-apply thermal label showing lot code, grade and CoC reference
Step 05 · Dispatch, customer distribution & traceback

"If a pigment supplier just flagged a REACH SVHC — which medical, food-contact and automotive customers are exposed?"

Every pallet ships with the CoC, GS1-128 SSCC, substance-status marks and a bag manifest tied to the released compound lot. When a supplier flag, a customer complaint or a REACH / RoHS substance event triggers a stop-sale, V5's lot + bag + gaylord tree paints the affected ranges and destinations — forward from the finished compound lot and backward to every input virgin resin, masterbatch, additive, regrind and packaging lot that built it. A CoC retraction with the customer recall pack drafts itself.

CoC retraction & recall packCustomer / molder / end-market traceForward & backward genealogy
The REACH SVHC & CoC recall tree

A pigment supplier confirms an SVHC contamination on color masterbatch lot CM-7740. V5 walks the tree — the finished compound lot that used it, the bag and gaylord ranges dispatched, the medical, food-contact and automotive customers exposed. Pull the lever to see the customer CoC-retraction pack assemble itself.

downstream · 4 molder & converter shipments
Medical device molder · Fremont CA
180 × 25-kg · PO 66420 · shipped
IV set molder · Salt Lake City UT
150 × 25-kg · PO 66471 · in transit
Dairy tub molder · Batavia IL
22 gaylords · PO 66503 · shipped
Snack tray thermoformer · Dallas TX
14 gaylords · PO 66519 · shipped
2 grade / SKU ranges dispatched
25-kg bag range B-3210–3540
330 bags · SKU 7714-PP-MED · USP Class VI
Gaylord range G-4110–4145
36 gaylords · SKU 7714-PP-FOOD · 21 CFR 177
1 finished compound lot · CoC record
CP-24-1104 · PP copolymer med / food grade
366 units · recipe rev C · MFI 12.2 · CoC rev C · 2-sig released
upstream · 4 input & regrind lots
Color masterbatch · lot CM-7740
Supplier S-118 · SVHC contamination
Virgin PP resin · lot PP-3310
Supplier S-042 · MFI verified
Antioxidant additive · lot AO-880
Supplier S-201 · assay ok
Regrind lot · RG-24-118
In-house · 12% ratio · same-grade
Affected units
0
Molders notified
0
Forward depth
2 hops
Backward depth
4 lots
Running underneath · maintenance, purge & grade changeover

Extruder PM, grinder / pelletizer verification, dust collection & purge validation — on the same tablet as production.

Built-in CMMS with polymer-native asset types — twin-screw and single-screw compounding extruders, side-feeders, underwater and strand pelletizers, dryers, silos, gravimetric feeders, colour masterbatch dosers, cyclones, dust collectors, magnets, metal detectors, checkweighers, bag-off / gaylord / octabin fillers, drying hoppers and palletisers. PM schedules, screen-pack change registers, purge validation, magnet / metal-detector test-piece verification and grade-changeover sign-off run on one calendar. An out-of-cal instrument, an overdue PM task or a failed metal-detector verification physically refuses to release a compound lot.
Maintenance engineer in navy coveralls and safety glasses servicing a stainless steel twin-screw compounding extruder and pelletizer with a torque wrench and tool trolley in a clean plastics production room
Running underneath · quality, REACH / RoHS & customer schemes

Quality, REACH / RoHS substance control and Certificate of Compliance control run through every compound lot — not stapled to the record at the end.

Incoming inspection, in-process checks, two-signature release, internal audits, CAPA, customer complaints, REACH SVHC dossier, RoHS declaration and customer-scheme (IATF 16949 PPAP, ISO 9001 audit, medical / food-contact) evidence packs — all in one loop, all tied to the affected compound lot and input lot. Operators are blocked at the workstation if grade or PPE training has lapsed. Suppliers are blocked at goods-in if a CoA, REACH declaration or food-contact / USP VI statement has lapsed. Audit evidence — IATF 16949 PPAP, ISO 9001, FDA 21 CFR 177, USP Class VI, REACH ECHA and RoHS — is a single indexed export.
Polymer QA reviewer in a modern office reviewing an electronic Certificate of Compliance and REACH SVHC substance report on dual monitors with resin grade spec limits and test results visible
The V5 quality kit — for a plastics compounder

Every quality feature in V5 — mapped to a plastics compounder & molder.

The same platform that runs pharmaceuticals and human food — set up for the way a compounder or molder actually receives, dries, dispenses, extrudes, pelletises, tests, bags-off and releases a lot under ISO 9001, IATF 16949, 21 CFR 177, USP Class VI, REACH and RoHS.

Approved Supplier Program & REACH / RoHS

Configurable per virgin resin, masterbatch, additive and pack. CoA + REACH SVHC + RoHS + food-contact / USP Class VI verified at receipt; expired qualification blocks goods-in automatically.

plastics compounder: PP copolymer · supplier S-042 · CoA + REACH · food-contact

Gravimetric dispense & regrind by shot

Loss-in-weight feeders and gravimetric dispense verify virgin resin, masterbatch and additives to the gram. Regrind ratio is captured shot-by-shot — an OOS regrind ratio opens a deviation.

plastics compounder: Blue MB · 3.2 kg · ±0.5% · regrind 12.4%

Two-signature release

Production + QA review-and-release before any blend ships. Every gate signed with a validated e-signature — identity + meaning captured.

plastics compounder: Lot CP-24-1104 · 2-sig released

Deviation, complaint & customer feedback

One workflow from issue raised through root cause, action, verification and close. Linked to the affected blend, workstation, operator, supplier and customer — customer complaint routes to the correct account team.

plastics compounder: CX-4408 · molder incoming-QA · MFI OOS

Recipe & CoC lockdown

Recipes are immutable, rev-locked and tied to the customer's current spec. Current-rev customer CoC template pinned per lot — the CoC engine refuses to render a superseded spec.

plastics compounder: PP med grade · rev D · CoC rev D

Supplier scorecards & re-qualification

On-time delivery, CoA quality, REACH / RoHS status, food-contact / USP VI statements, deviation rate and audit findings rolled into a live supplier score. Expired qualifications block goods-in automatically.

plastics compounder: Supplier S-042 · OTIF 96% · REACH ok · RoHS ok

REACH SVHC & RoHS chain of custody

REACH SVHC, RoHS, 21 CFR 177 food-contact and USP Class VI status carried lot-by-lot from receiving through extrusion, pelletising, packaging and shipping — with substance mass-balance evidence enforced at each step.

plastics compounder: REACH mass-balance · in 3,200 kg → out 3,188 kg · 99.6%

Auto customer-CoC in your customer's format

The CoC engine renders results into the customer's preferred template — their column order, method IDs, spec limits, substance status and letterhead — from released lot data at bag-off.

plastics compounder: PO 44120 · med device molder CoC · 5 columns · MFI pass

Retain samples & aging studies

Retain samples booked into the retain library per lot with location, disposition and expiry. Aging studies scheduled per grade — MFI, tensile, colour ΔE and UV / thermal aging pull-points tied to the recipe.

plastics compounder: CP-24-1104 · retain 2 × 500g · aging 24-mo
Talks to your kit

Live on your extruders, feeders, pelletizers and bag-off lines — no rip-and-replace.

We connect at the level your engineers and QA team expect — OPC UA, Modbus, MQTT, REST, EDI, file drops, SQL. Most compounders are live on day one with the extruders, side-feeders, pelletizers, gravimetric feeders, colour dosers, dryers, metal detectors, checkweighers and bag-off lines already installed.

Extrusion, dispense & pelletising

OPC UA and Modbus links to Coperion, Leistritz, KraussMaffei-Berstorff, JSW, Steer twin-screw compounding extruders and side-feeders; K-Tron, Coperion, Schenck, Acrison, Movacolor loss-in-weight and gravimetric feeders; Gala, BKG and Rieter underwater and strand pelletizers. Screw speed, barrel temperature, torque, melt temp / pressure and dispensed mass logged straight to the lot.

Screens, magnets, metal detect & checkweigh

Screen-pack change registers, Bunting and Eriez magnets; Mettler-Toledo Safeline, Loma, Anritsu, Ishida metal detectors and checkweighers. Reject events, test-piece verifications and giveaway data streamed to the lot — a failed verification hard-stops the line.

Bag-off, gaylord / octabin fill & label

Concetti, Premier Tech, Haver & Boecker, Statec Binder bag-off and gaylord / octabin fillers; Videojet, Domino, Markem-Imaje, Zebra thermal-transfer and print-and-apply labellers. Current-rev customer bag label and CoC reference pinned per lot at the line.

Lab instruments & LIMS

Melt flow indexer, tensile tester, DSC / TGA, FTIR, ICP-MS, LC-MS/MS, moisture (Karl Fischer), colour spectrophotometer, density balance. Direct connectors for Waters, Agilent, Thermo Scientific, PerkinElmer, Mettler-Toledo, HunterLab and Malvern Panalytical.

ERP, WMS & customer portals

SAP, NetSuite, Microsoft Dynamics 365, Oracle, Infor, IQMS, Plex. Customer EDI, ASN and customer-CoC delivery per customer preference — email, SFTP, portal upload or API. IATF 16949 PPAP submission packs assembled from released lot data.

BI & data warehouse

Power BI, Tableau, Looker, Snowflake, Databricks. Direct SQL access to your tenant — your data, your queries, your validated reports.

Audit-ready, every day

ISO 9001, IATF 16949, 21 CFR 177, USP VI, REACH & RoHS — at the data layer.

The records build themselves as the blend is executed. When the FDA FSMA inspector, an IATF 16949 PPAP auditor, an ISO 9001 auditor, an FDA food-contact investigator or a customer-audit team walks in, the evidence pack is one click — not a week of re-assembly.

21 CFR 177
FDA indirect food additives — polymers
USP Class VI
Plastics for medical / pharmaceutical use
IATF 16949
Automotive QMS
ISO 9001
QMS baseline for industrial supply
REACH / RoHS
EU substance compliance
Go-live in 10 to 16 weeks

Fixed-price, named team, one product family live before you pay for the next.

  1. Week 1–4·step 01
    Discovery & floor scan

    We walk one product family with your team — recipes, customer spec library, CoC templates, regrind rules, REACH SVHC / RoHS status, food-contact / USP VI statements, existing ERP and WMS fields. Out: a fixed scope and price.

  2. Week 5–9·step 02
    Configure & integrate

    Material master, recipes, per-customer specs, LIMS methods (MFI, tensile, thermal, FTIR ID, REACH screen), customer CoC templates, extruder / feeder / pelletizer / metal-detector / bag-off integrations and ERP feeds loaded.

  3. Week 10–13·step 03
    Pilot & train

    One product family live in pilot. Three-shift operator training on the floor with the actual UI — not slides. UAT signed by QA, production and operations.

  4. Week 14–16·step 04
    Go live & hyper-care

    Cut over. Two weeks of hyper-care with your named delivery team on-site. KPIs published on the wall before we leave.

Cloud-hosted, US & EU regions· SOC 2 controls, SSO, audit log· Validated change control, QA-signed release
What buyers ask us

The first six questions on every plastics compounding RFP.

How does V5 auto-generate a Certificate of Compliance in the customer's preferred format?
Each customer has one or more CoC templates in V5 — their column order, method IDs, spec limits, units, substance status (REACH SVHC, RoHS, 21 CFR 177, USP Class VI), header, letterhead and delivery channel (email, SFTP, portal upload, API). At bag-off, the CoC engine pulls released lot data into the correct template per customer and per grade. A recipe change or a spec-column change flags the template as out-of-date and routes it through QA before the next bag ships. There is no retyping, and there is no way for a superseded spec to render on the shipped CoC.
How does V5 handle FSMA Preventive Controls and FSVP for imported ingredients?
REACH SVHC and RoHS statuses are first-class attributes on the resin, masterbatch and additive master and inherit to every recipe and lot. Supplier substance declarations, safety data sheets and reassessment schedules are tied to each supplier and each material. An expired REACH declaration or a new SVHC candidate-list entry blocks the pallet at goods-in and re-scores the affected lots — not after they are compounded.
How does V5 track regrind and virgin ratios by shot, and enforce the customer spec?
Regrind and virgin ratios are captured shot-by-shot from the gravimetric feeders and enforced against the customer's spec for the grade. An over-limit regrind ratio hard-stops the line and opens a deviation. Regrind lots carry their own genealogy — same-grade, same-recipe, single-heat-history — so a mis-graded regrind can never be blended into a food-contact or medical grade. The CoC reports the actual regrind ratio per lot when the customer requires it.
Will V5 talk to our extruders, side-feeders, pelletizers, metal detectors and bag-off lines?
Almost certainly. We support OPC UA, Modbus, MQTT, REST, EDI and direct SQL — with working connectors for Coperion, Leistritz, KraussMaffei-Berstorff, JSW, Steer extruders and side-feeders; K-Tron, Coperion, Schenck, Acrison, Movacolor feeders; Gala, BKG and Rieter pelletizers; Bunting and Eriez magnets; Mettler-Toledo Safeline, Loma, Anritsu, Ishida metal detectors / checkweighers; Concetti, Premier Tech, Haver & Boecker, Statec Binder bag-off / gaylord fillers; and Videojet, Domino, Markem-Imaje, Zebra label printers.
We toll-compound for multiple customers on one extruder line — how does V5 keep them separate?
Customer roles are explicit on every recipe, lot, e-signature and audit event. Each customer's recipes, spec library, CoC templates and artwork sit in their own tenant workspace with an audit-log wall between them, and QA sign-off routes to the correct customer's spec. A customer sees their lots and CoC history; the toll compounder sees the site — both defensible under ISO 9001, IATF 16949 and customer supply agreements.
What about IT — validated change control, SOC 2 and GFSI / certifying-body audit prep?
Cloud-hosted in US and EU regions, SOC 2 controls, SSO (SAML / OIDC), full audit log and validated change-control process applied to every regulated screen. Where an IATF 16949 PPAP, ISO 9001, FDA food-contact, USP Class VI or REACH ECHA audit is scheduled, the evidence pack maps section-by-section — supplier program, recipes, dispense, regrind, extrusion, MFI, tensile, substance, CoC, traceability, recall — from released lot data.
Ready to see it on your compound lot record?

Book a 30-minute walkthrough with a plastics & resins specialist.

We'll show a live self-building compound-lot record, recipe lockdown, gravimetric dispense and extruder-parameter capture, regrind-by-shot tracking, MFI / tensile / thermal in the LIMS, two-signature release, auto CoC generation in your customer's format at bag-off and a mock REACH SVHC traceback — on a workspace seeded for a working plastics compounder.

Fixed-price go-live · No platform lock-in · Onboard in 10–16 weeks