Total Solutions for Biopharma
Complete Turnkey Biopharma Lines — Built for Quality and Compliance, Engineered for Output
ARGOTEX delivers total biopharma manufacturing solutions — integrating cleanroom environments, process vessels, isolator systems, and SCADA controls, all validated end-to-end (IQ/OQ) under PIC/S GMP to guarantee consistent quality and measurable production results.
Founded by biopharmaceutical engineering specialists with over 50 years of cumulative international GMP experience.
Complete Coverage Across All Dosage Forms
50+
Cumulative Years of Biopharma Expertise — Led by senior validation & design engineers
100%
IQ/OQ Validation Success — Zero audit failures in local & international inspections
21 CFR PART 11
21 CFR Part 11 Compliant Software — Cryptographically signed audit trails
Target Industries
Advanced engineering solutions tailored to strict regulatory standards across the pharmaceutical, biological, and medical services industries.
Pharmaceuticals
High-speed formulation lines and process piping compliant with PIC/S GMP.
Biotech
Advanced sterile isolation and filling systems.
Medical Devices
Certified cleanroom environments for medical device manufacturing.
Nutraceuticals & Food
Capsule/tablet blending-filling lines for nutraceuticals, paired with sanitary stainless piping.
Medical-Grade Cosmetics
Emulsifying mixers and contamination-free topical lines.
Production Line Engineering Solutions
Explore our turnkey solid, liquid, and semi-solid formulations systems integrated for sterile GMP environments.
Sterile Production
Sterile Production
Turnkey design of high-speed sterile filling lines and isolation barriers (Isolator) to guarantee absolute sterility and particulate control.
- Barrier Isolator Systems
- Non-contact peristaltic fill pumps
Solid Dosage
Solid Dosage
High-yield tablet press lines with closed weight feedback loop controls, capsule filling units, and continuous coating lines in a closed system to reduce dust dispersion. Packing system.
- 100% tablet weight control systems
- Capsule filling for powder/pellets
- Coating lines
Semi-Solid Dosage
Semi-Solid Dosage
Vacuum homogenizing emulsifier vessels for fine ointment blending, preventing air pocket bubbles. Integrated with automated pharmaceutical tube filling and crimp sealing systems.
- Vacuum Homogenizer mix vessels
- Automated cream tube filling
- CIP sanitizing loops
Liquid Dosage
Liquid Dosage
Syrup and suspension preparation vessels connected to automated bottle wash, filling, and cap torque controllers. Complete line design including volume verification cameras.
- CIP/SIP mixing vessels & pipes
- Low-tolerance volumetric filling pumps
- Final inspection cameras
The Biopharma Plant Delivery Journey
From the initial CAD conceptual flow designs to international regulatory audit validations, we manage and assume complete ownership of your production lifecycle.
Conceptual Design & P&ID
Conceptual Design & P&ID
We draft compliance layout flows for HVAC systems, materials, and operators using 2D layout diagrams. Developing initial P&ID diagrams ensuring early validation mapping.
Deliverables / ผลส่งมอบ:
- Conceptual 2D Layouts
- Material & Personnel Flows
- P&ID Process Diagrams
Modular Cleanroom & HVAC Build
Modular Cleanroom & HVAC Build
Installation of modular, non-shedding cleanroom wall panels and ceiling systems. Integrating custom AHUs with HEPA filtration to maintain precise temperature, humidity, and differential pressures — sized for energy-efficient operation to keep the facility's long-term utility footprint low.
Deliverables / ผลส่งมอบ:
- Modular cleanroom wall structures
- Digital air pressure panels
- HEPA Terminal Filter setups
Process Integration
Process Integration
Connecting machinery and equipment across the production line so it runs as one seamless system — reducing handoff delays between stages and helping customers keep production continuous and on target for their output goals.
Deliverables / ผลส่งมอบ:
- Line-wide machine connectivity layout
- Automated inter-machine material conveyance
- Full-line interoperability commissioning test
Upgrade Computer Data Control System
21 CFR Part 11
Upgrade the computer data control system to meet FDA 21 CFR Part 11 data security requirements, with tamper-proof audit trails and unique, attributable electronic signatures — the same OPC UA connectivity this upgrade establishes also integrates with serialization and track-and-trace systems to fully trace the origin of every production lot.
Deliverables / ผลส่งมอบ:
- FDA Part 11 secure audit trails
- OPC UA system connectivity
- Unique e-signatures (biometric / secure PIN)
Qualification & Validation
Qualification & Validation
Executing detailed IQ/OQ validation protocols to confirm the production line's installation and operation meet requirements.
Deliverables / ผลส่งมอบ:
- Comprehensive IQ/OQ binders
- Software validation reports
- Risk-assessment matrices (FMEA)
Why ARGOTEX
Total Solutions for Biopharma. We design, build, and validate production lines to deliver quality and measurable results — owning the verification process rather than just selling machinery.
End-to-End System
We design and build the cleanroom, then source and install the production machinery — through to IQ/OQ commissioning.
Global Standards
Our processes comply with PIC/S and GMP standards.
After Sales Service
Custom calibration scheduling and preventive maintenance contracts.
Downloads Document
Access detailed catalogs, product brochures, modular cleanroom datasheets, and whitepapers.
ARGOTEX Corporate Capability & Installation Profile
Overview of modular panel options, HVAC parameters, line integrations, client references, and GMP checklists (PDF file).
Consultation Engineering
Provide your biopharmaceutical project parameters to receive a conceptual layout draft and turnkey proposal options.