MCF1 Changeover Playbook: Fast, Clean, and Audit‑Friendly Oil Filling at Scale

Introduction

High-throughput oil filling operations demand more than just speed—consistency, cleanliness, and compliance are non-negotiable when downtime and audit risks affect your bottom line. For production supervisors and QA leads running the Thompson Duke MCF1 semi-automatic filling line, mastering rapid, GMP-adjacent changeovers isn’t just good practice—it's the cornerstone of operational excellence.

This playbook delivers a changeover SOP that unites daily productivity with regulatory credibility, drawing on Thompson Duke’s certified best practices and industry-vetted QA/QC strategies. Discover how ergonomic design, kit-based consumables, and in-process validation optimize both throughput and compliance on every shift.

---

Why Changeover Mastery Matters

Changeover can be the single largest source of avoidable downtime or cross-contamination. Each product, batch, or oil type switch amplifies risk and diminishes ROI if not handled with scientific precision and ergonomic efficiency.

Top pain points at scale:

• Lost production hours from full teardown vs. smart kit-based swaps
• Incomplete draining or cleaning leading to flavor/strain residuals or cross-contact allergens
• QA/QA hiccups from documentation gaps—traceability and rapid checks are vital for audit readiness
• Operator fatigue and repetitive strain from manual, awkward reassembly

With cETLus, GMP-ready MCF1s, and the right SOP, you can reliably scale batch changeovers in less than one minute [source: MCF1 spec sheet], minimize product loss to under 1g per switch, and drive safe, validated throughput day after day.

---

The MCF1 Changeover SOP: Lossless, Clean, and Traceable

1. Pre-Changeover Staging

• Staging consumable kits: Ensure all critical components—dispense syringe, reservoir, tubing, needles, and valves—are available pre-sterilized or single-use.
• Batch documentation: Fill in pre-changeover logs, including outgoing batch code and target fill weight (per line master spec, e.g., 0.5g, 1g, etc.).
• QA checkpoint: Confirm last batch fill/weight data and any in-process deviations logged in your batch record.

2. Draining and Initial Rinse

• Activate foot pedal to drain residual oil into a designated, traceable waste container.
• Use minimal volume air purge if necessary (MCF1 supports fully draining via the built-in system; verify with current model’s user manual).
• Wipe down accessible surfaces with industry-recommended food-safe solvents—isopropyl alcohol (IPA) 70%, ethanol, or detergent blends designed for botanical oil residues (see Alconox industry notes).

3. Consumable Swap—Ergonomics & Speed

• Remove and discard used dispense syringe, product reservoir with lid, heat lamp bulbs, and needle set according to your site’s GMP waste protocol.
• Snap in new or sanitized syringe, reservoir, and needle kit (Urth & Fyre provides complete kits). No tools required: all major parts are Luer Lock for instant fit and ergonomic hand-off—eliminates operator strain from over-tightening or awkward access.
• Visual and tactile checks: Confirm all O-rings, gaskets, and joints seat fully/cleanly before proceeding.

Downtime math:

• Kit swap time: < 1 minute for experienced operators, 2-3 minutes for new staff with full guidance.
• Full teardown/clean: 20+ minutes (drain, disassemble, deep clean, full validation, reassemble, function test). Savings: At least 10X less downtime per changeover—when switching oils or flavors up to 4x/shift, that’s 1.25 hours/day regained per MCF1 line.

4. Sanitization and Cleaning Validation

• Wipe or rinse new consumables with designated solvent if not pre-sterilized. For heavy residues, consider alkaline detergent (e.g., Keylajet or Alcojet from Alconox).
• Rinse with sterile water, if required by your SOP. Dry with lint-free wipes.
• Visual inspection: No visible oil, cloudiness, or particulate. Swab or rinse test for validation if under GMP audit conditions—document all results with lot/date/time.
• GMP-adjacent checklist: Equip changeover logs with checkboxes for all above steps, and sign-off lines for both operator and QA.

5. QA Metrics & In-Process Checks

• Initial fill/weight check: Dispense first few units to tare-calibrated scale (precision to 0.001g recommended for critical applications; NTEP-compliant checkweigher if automated).
• Target fill: ±0.03g of label spec (per typical vape cartridge industry standards, adjust for your compliance needs).
• Leak test: Place filled units tip down for 10-20 minutes. Scan for residue/sweat; recheck o-ring seat if excess seen.
• Potency integration points: If integrating in-process potency or QA sampling (e.g., using HPLC or portable analyzers), pull a sample after the 5th unit post-changeover for baseline validation.
• Final documentation: Update production and QA logs including:
  • Time of change
  • Operator initials
  • Reservoir/kit lot #s
  • Validation results (weight, visual, leak, QA test)
  • Any deviations/notes

---

Ergonomics: Reduce Operator Fatigue, Prevent Mistakes

The MCF1’s benchtop and quick-swap design suit both standing or seated operation, minimizing repetitive strain. Syringe and reservoir assemblies are crafted for tool-less, gloved-hand operations to maximize speed and reduce slip/injury risk. Batch-to-batch downtime is further reduced by centralized, easy-access kit storage and staging.

For high-volume lines, pair your MCF1 with the Thompson Duke Press Machine (TPM)—it offers automated, multi-cartridge capping with integrated safety controls and GMP-compliant traceability, rounding out a closed-loop, audit-ready production train. See TPM details.

---

Audit Readiness: Minimal IQ/OQ, Maximum Traceability

• cETLus Certified, GMP-Ready: The MCF1 conforms to all electrical and operator safety standards applicable in North America; its changeover and cleaning workflow can be documented for ISO and 21 CFR Part 11-adjacent requirements.
• Traceability: Track all consumables (syringes, reservoirs, needles) by lot. Keep changeover, cleaning, and QA logs digital with time stamps and e-signature if required.
• Integration with TPM and in-process QA: Enables full batch traceability from fill to cap, with easy validation points for auditors or regulatory checks.

---

Consumable Kits and Urth & Fyre Value

Urth & Fyre supplies certified MCF1 units with pre-assembled consumable kits (dispense syringe, 140mL reservoir, full needle set, O-rings, cleaning tools, and more). This ensures:

• Rapid changeover (<1 min)
• Minimal training curve
• Compliance with validated SOPs and QA audit readiness

We also provide on-site and remote training, process consulting, and TPM integration—helping you tune your operation for maximum throughput and minimum downtime, while always remaining compliance-focused.

---

Takeaways & Implementation Checklist

• Adopt kit-based changeovers for all routine product/batch switches
• Pre-stage QA checkpoints (weight, leak, and in-process sample)
• Log every action—digital logs recommended for traceability
• Keep ergonomic swaps as the default—avoid full teardowns except for periodic deep cleans
• Integrate TPM for full-closure, audit-friendly lines

Need an MCF1 or consumable kit? Ready to optimize changeovers or train operators?

Explore our listings, get a consult, or purchase everything for toolkit-ready changeovers—visit Urth & Fyre MCF1 and let us help you scale with speed, safety, and repeatability in mind.

---

For more equipment, audit-ready best practices, and process improvement resources, visit Urth & Fyre.