cGMP Facility • Texas
(844)-323-5628
Supplements Manufacturing

Encapsulation Manufacturing

Precision-fill capsule production from bench to commercial scale under 21 CFR Part 111 cGMP.

Our Carrollton and Van Alstyne facilities operate fully automated capsule filling lines capable of producing vegetarian HPMC, standard gelatin, delayed-release enteric, and beadlet-filled capsules. All encapsulation runs are governed by in-process weight uniformity checks every 15 minutes, with hard capsule disintegration confirmed per USP <701> before batch release.

Request a Production QuoteConsult Technical Team

Supported Dosage Forms & Formats

Vegetarian HPMC Capsules (Size 000, 00, 0, 1, 2)Gelatin Capsules (Size 000, 00, 0, 1, 2, 3, 4)Enteric-Coated / Delayed-Release CapsulesBeadlet-Filled Capsules (extended-release pellets)Liquid-Filled Hard Capsules (LFHC)Dual-Chamber Separation Capsules

Quick Fact Sheet

Key production parameters

Minimum Order Quantity

1,000 finished units

Standard Lead Time

4–6 weeks from formula approval and PO

Cleanroom Standard

ISO Class 8 / 21 CFR Part 111 cGMP

Packaging Compatibility

  • HDPE Bottles (60cc – 500cc, child-resistant caps)
  • PET Amber Glass Bottles
  • Blister Packaging (via partner)
  • Bulk Drums (for resellers / repackagers)
  • Stand-Up Pouches with zipper seal
  • Clinical trial unit-dose sachets

Mutual NDA Standard: All formula details, BOM data, and brand concepts shared during the quoting process are protected under a reciprocal Non-Disclosure Agreement executed before technical evaluation begins.

Laboratory Asset Pipeline

Machinery & Specimen Visual Verification

Inspect actual cleanroom machinery, finished dosage macro specimens, and packaging protocols dedicated to encapsulation manufacturing.

Clear vegetarian capsules with standardized golden extract beads
Specimen Macro
Weight Uniformity ±1.5% | USP <701> Disintegration

HPMC Vegetarian Two-Piece Capsules

Size 00 and 0 clear vegetarian capsules filled with standardized golden botanical extracts and delayed-release beadlets.

316L stainless steel rotary capsule filling line in cleanroom
Machinery Suite
Output: Up to 150K Caps / Shift | 316L Stainless Steel

High-Speed Automated Rotary Encapsulation Line

Multi-tamping capsule filling machinery outputting up to 150,000 units/shift with continuous weight rejection.

High-speed packaging line with induction sealing and tamper-evident banding
Packaging & QA
Velocity: 80-120 Bottles/Min | 100% Induction Verified

Automated Bottling & Induction Foil Sealing

Integrated electronic counter, dessicant insert, induction seal, and automated bottle labeler.

Engineering Specification Table

ParameterSpecification / ValueNote
Minimum Order Quantity (MOQ)
1,000 units
MNL SPEC
Standard Commercial Run
5,000 – 100,000+ units per batch
MNL SPEC
Line Speed (automated)
Up to 150,000 capsules / 8-hour shift
MNL SPEC
Fill Weight Tolerance
±3% of target fill weight (per 21 CFR 111.73)
MNL SPEC
Weight Uniformity Check Interval
Every 15 minutes during production
MNL SPEC
Disintegration Time (HPMC)
≤ 30 minutes per USP <701>
MNL SPEC
Disintegration Time (Enteric)
≥ 60 minutes acid stage, complete dissolution in buffer
MNL SPEC
Capsule Moisture Content Control
Relative humidity maintained 35–55% RH in filling area
MNL SPEC
Cleanroom Classification
ISO Class 8 / cGMP 21 CFR Part 111 compliant
MNL SPEC
Pilot Batch Lead Time
14–21 business days from raw material receipt
MNL SPEC
Standard Batch Lead Time
4–6 weeks from formula lock and PO confirmation
MNL SPEC

Specifications are representative of standard production parameters. Project-specific values may vary based on formula requirements, ingredient characteristics, and target packaging format. Contact our engineering team for exact specifications relevant to your batch.

Quality Assurance & Verification Protocol

Every encapsulation manufacturing batch passes through a four-phase analytical verification workflow before Certificate of Analysis issuance and release.

01

Raw Material Identity & Purity

All active and excipient raw materials are identity-confirmed before release to production. COA cross-reference, organolpetic checks, and FTIR or HPLC assay performed based on ingredient risk classification.

COA cross-reference verificationFTIR spectroscopy identityHPLC potency assay (actives)Heavy metals screen (ICP-MS)
02

In-Process Quality Monitoring

Continuous in-process controls during encapsulation: fill weight uniformity sampled every 15 minutes, visual capsule closure inspection, and real-time environmental monitoring of cleanroom temperature and RH.

Fill weight uniformity (10-capsule sample per USP <905>)Capsule closure and lock-ring integrityEnvironmental monitoring (temp, RH, particulates)In-process yield tracking vs. theoretical
03

Finished Product Testing

Complete finished-goods analytical release: potency assay against label claim, microbial enumeration (TPC, E. coli, Salmonella, Yeast & Mold), disintegration, and physical attribute confirmation.

Label claim potency assay (HPLC/UV-Vis)Total aerobic plate count (TPC)Yeast & mold enumerationSalmonella & E. coli absence confirmationDisintegration USP <701>Capsule appearance / color / print QC
04

Certificate of Analysis (COA) Release

QA Director review and sign-off of the complete batch record and analytical results. COA issued on MNL letterhead with full traceability to raw material lot numbers. No batch ships without COA authorization.

Full batch record review (21 CFR 111 compliant)QA Director COA signature and dateLot number and expiration date assignmentClient COA transmittal with release authorization

Certificate of Analysis (COA) — Issued Per Batch

Every commercial batch receives a QA Director–signed Certificate of Analysis on MNL letterhead. The COA documents all test parameters, analytical methods, results versus specification, and full lot traceability to raw material COAs. No batch ships without COA authorization.

Production Specification Request

Request a Quote for Encapsulation Manufacturing

Submit your project brief through our structured multi-step quote engine. Pre-select Encapsulation Manufacturing as your target manufacturing service. Our Carrollton, TX formulation and production team will provide a preliminary feasibility response within 24–48 business hours, under mutual NDA before any formula details are exchanged.

  • Preliminary quote returned within 24–48 business hours
  • Mutual NDA executed before formula review
  • Direct access to MNL formulation chemists
Request Quote for Encapsulation Manufacturing

Or contact our engineering team directly

(844)-323-5628info@micellecosmeticslabs.com

Mon – Fri: 8:00 AM – 5:00 PM CST. Facility visits by advance appointment.

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