cGMP Facility • Texas
Texas Manufacturing Infrastructure • FDA Registered

Engineered for Purity. Pharmaceutical-Grade Infrastructure.

Dietary supplement manufacturing infrastructure operating under strict 21 CFR Part 111 cGMP standards across Carrollton and Van Alstyne, Texas. Featuring terminal HEPA cleanroom suites, tight relative humidity control (<20% RH), and automated rotary tableting and encapsulation lines.

Facility Engineering DataTexas, USA
48,000+
Sq. Ft. Total Footprint
< 20%
RH Controlled Suites
99.97%
HEPA 0.3µm Air Capture
> 5M
Weekly Capsule Throughput
4717 Plano Parkway Suite #150, Carrollton, TX 75010
HVAC & Cleanroom Specifications

Infrastructure Environmental Controls

Dietary supplements are sensitive to humidity, cross-contamination, and microbial intrusion. Our HVAC and clean utility architecture is modeled after modern pharmaceutical engineering standards.

HEPA Air Filtration & Air Changes

Terminal HEPA filtration captures 99.97% of airborne particulates down to 0.3 microns. Cleanroom suites maintain 20 to 30 air changes per hour (ACH) to ensure continuous dilution and evacuation of any ambient particulate matter.

Filter Rating: 99.97% @ 0.3 Micron • ISO 7/8

Differential Pressure Cascades

Positive air pressure cascades (+15 to +25 Pascals) between processing suites and gowning airlocks ensure that air always flows outward, preventing external particulate entry into active open-product zones.

Differential: +15 to +25 Pa Over Corridors

Desiccant Low-RH% Dehumidification

Specialized suites for effervescent drink powders and hygroscopic amino acids are equipped with industrial desiccant wheel dehumidifiers capable of holding relative humidity strictly below 20% to prevent clumping.

Target Humidity: < 20% RH @ 68°F ± 2°F

USP Purified Water & RO/DI Loop

Continuous multi-stage Reverse Osmosis (RO) with Electro-Deionization (CEDI) and UV loop sanitization producing purified water meeting USP monographs for liquid drops, tinctures, and sanitation CIP procedures.

USP Conductivity Monitored Continuous

Sanitary Epoxy & Coved Transitions

All production flooring is finished with seamless, chemical-resistant antimicrobial polyurethane epoxy with coved wall-to-floor junctions eliminating 90-degree corners where microbial bioburden or powder residue could harbor.

Coved Baseboards • Seamless Monolithic Epoxy

Continuous Environmental Monitoring

24/7 centralized Building Management System (BMS) logging temperature, humidity, pressure differentials, and dust particle counters with automated SMS/email alerts on any out-of-spec deviation.

24/7 Datalogging • Audit-Ready PDF Records
Campus Zoning & Workflow

Specialized Production Suites & Functional Zones

Segregated physical layouts to guarantee unidirectional flow of personnel and materials, preventing cross-contamination between botanicals, proteins, and active compounds.

ISO Class 7 / Class 8 Equivalent

Controlled RH% Cleanrooms & Production Suites

Capacity: 18,500 sq. ft. dedicated cleanroom footprint

Engineered specifically for hygroscopic powders, botanical extracts, and effervescent formulations that degrade under atmospheric moisture.

Environmental Controls: Positively pressured (+20 Pa), HEPA filtered, Desiccant RH% < 20% to 40%
Primary Machinery In Suite:
  • Desiccant dehumidifier units
  • Digital magnehelic pressure gauges
  • HEPA ceiling modules
  • Gowning airlocks
Dust-Controlled Explosion-Proof Enclosures (Class II Div 1)

High-Capacity Industrial Blending Suites

Capacity: Up to 25,000 lbs / 11,500 kg per day across multi-shift blending runs

Precision micro-ingredient dispersion ensuring homogeneous coefficient of variation (<3% CV) even with active ingredients dosed as low as 50 mcg.

Environmental Controls: Dedicated reverse-pulse dust extraction, negative dust perimeter, climate controlled
Primary Machinery In Suite:
  • V-Blenders (10 cu.ft. to 150 cu.ft.)
  • Sanitary Ribbon Blenders (3,000L)
  • Conical screw blenders
  • Fluid-bed spray agglomerator
Pharma-Grade Secondary Containment

High-Speed Encapsulation & Tableting Core

Capacity: > 5,000,000 capsules / week; > 3,500,000 tablets / week

High-efficiency solid dosage manufacturing equipped with real-time compaction force monitoring to guarantee tablet friability and dissolution.

Environmental Controls: Continuous particulate extraction, temperature regulated at 68°F ± 2°F
Primary Machinery In Suite:
  • Automated Capsule Fillers (Size 00, 0, 1, 2, 4)
  • Multi-station Rotary Tablet Presses
  • Deduster & Metal Detector combos
  • Weight checkweighers
Sanitary Packaging Zone

Automated Packaging & High-Speed Bottling Lines

Capacity: 60 to 90 finished bottles per minute per line

End-to-end automated secondary packaging delivering hermetically sealed, tamper-evident bottles, induction heat seals, and laser batch coding.

Environmental Controls: Clean ambient airflow, positive pressure conveyor tunnels
Primary Machinery In Suite:
  • Electronic multi-channel optical counters
  • Automatic inline desiccant inserters
  • Induction cap sealers
  • Shrink wrap & pressure-sensitive labelers
Biosafe Analytical Testing Suite

In-House QA/QC Analytical & Wet Chemistry Lab

Capacity: Comprehensive lot release testing turnaround under 5 to 7 business days

Equipped to handle raw material quarantine verification, real-time in-process checks, and final release COAs without relying solely on outside labs.

Environmental Controls: Vibration-isolated balance tables, dedicated chemical fume hoods, temperature logged
Primary Machinery In Suite:
  • HPLC / UPLC units
  • ICP-MS trace metal analyzer
  • FTIR spectrophotometer
  • USP automated dissolution baths
  • Microbiology incubators
Capacity & Operational Scale

Machinery & Daily Throughput Matrix

High-speed automated manufacturing lines engineered for tight operational tolerances, minimal changeover downtime, and continuous in-line quality verification.

Machine CategoryModel & Engineering SpecsNominal ThroughputOperational TolerancesSupported FormatsIn-Line Quality Monitoring
Automated Capsule FillingRotary Multi-Tamping Pin Fillers> 5,000,000 capsules / week±1.5% fill weight varianceSize 00, 0, 1, 2 (Gelatin, HPMC Vegetarian, Acid-Resistant)100% optical weight checkweighing & electronic capsule height sorting
High-Speed Rotary Tableting36-Station Double-Sided Rotary Tablet PressesUp to 150,000 tablets / hourFriability < 0.5%, Hardness 4 - 18 kpRound, Oval, Oblong, Chewables, Bi-layer, SublingualsAutomatic rejection gate based on punch-compression force deviation
Sanitary Powder BlendingSanitary 316L Stainless Steel V-Blenders & Ribbon Blenders25,000 lbs (11,300 kg) / dayCoefficient of Variation (CV) < 3.0%Plant & Whey Protein, Hydration Electrolytes, Nootropics, Pre-workouts10-point core thief sampling across blender vessel prior to discharge
Automated Bottling LineMulti-Head Optical Counting & Inline Capping System60 - 90 bottles / minute100% count accuracy with dual infra-red beams60cc to 950cc PET & HDPE bottles, glass amber jarsEnercon induction seal integrity verification & vision inspection
Multi-Lane Stick Pack & Sachet PackagingVertical Form-Fill-Seal (VFFS) High-Speed MachineryUp to 120 sachets / minute±0.05g fill weight accuracySingle-serve drink mixes (2g - 25g), Gusset foil pouchesContinuous nitrogen flushing with residual O2 monitoring (<2%)
Liquid Tincture & Dropper FillingPiston & Peristaltic Cleanroom Liquid Fillers3,000 bottles / hour±0.2 ml volumetric dosage accuracy15ml, 30ml, 60ml, 120ml glass tincture bottles with graduated pipettesIn-line torque monitoring for tamper-evident closures
All machinery sanitized per validated cGMP Clean-In-Place (CIP) & Clean-Out-of-Place (COP) protocols.Standard line clearance: Swab tested for ATP & micro residue
Interactive Facility Walkthrough

Inside Our Texas Manufacturing Core

Step through our Carrollton and Van Alstyne facilities. Explore five critical manufacturing stages engineered to meet strict 21 CFR Part 111 standards.

High-tech ISO 7 pharmaceutical cleanroom with sterile white walls and HEPA filtration
FIG. 07 // ISO CLASS 7 CLEANROOM SUITE25-30 ACH • +20 PA POSITIVE

ISO Class 7 cGMP Primary Cleanroom Suite

Positive pressure (+20 Pa) suites equipped with terminal HEPA filtration (0.3 micron at 99.97% efficiency) eliminating ambient airborne particulates.

Operational Throughput Specification:
25-30 Air Changes / Hr
Carrollton Texas Cleanroom Campus
CAMPUS 01 • CARROLLTONISO 7 / ISO 8 Suites
FIG. 07 // PRIMARY CLEANROOM CORECARROLLTON, TX

Analytical QA & Cleanroom Encapsulation Center

Location: 4717 Plano Parkway Suite #150, Carrollton, TX 75010. Houses our in-house HPLC/ICP-MS analytical testing laboratory, cleanroom capsule/tablet manufacturing lines, and executive client formulation suites.

ISO 7 / ISO 8 Positive-Pressure Cleanrooms
HPLC, ICP-MS, FTIR & Rapid Microbial QC Lab
R&D Flavor Development Lab & Bench Sampling
Van Alstyne, TX climate-controlled finished goods staging warehouse with barcoded pallet racking
CAMPUS 02 • VAN ALSTYNE25k lbs / Day Blending
FIG. 12 // FINISHED GOODS LOGISTICS HUB68°F ± 3°F • BARCODED FIFO

Bulk Powder Blending & High-Speed Bottling Hub

Location: Van Alstyne, TX. Our high-capacity industrial production campus featuring 25,000 lbs/day blending capacity, automated high-speed bottling conveyors, and 65,000 sq. ft. of climate-controlled warehousing.

316L V-Blenders & Ribbon Blenders (25k lbs/day)
Automated 80-120 bottle/min packaging line
Climate-controlled storage & nationwide LTL logistics
Direct Cleanroom Access

Verify Our Capabilities Firsthand

Experience our cleanroom disciplines, environmental controls, and automated throughput in person. Speak directly with our Chief Formulator and VP of Quality in Carrollton, Texas.

ISO Class 8 Cleanrooms & HEPA FiltrationReal-Time Differential Pressure CascadesOn-Site HPLC / ICP-MS Quality Assurance Laboratory