OUR FACILITY
Built for Precision
Engineered for Scale
Wells Pharma’s Houston facility is a purpose-built, FDA-registered 503B outsourcing facility operating under cGMP standards, designed from the ground up to support the preparation of safe sterile products for hospitals and surgery centers nationwide.
Facility At-a-Glance Stats
24 Hoods
ISO-5 vertical laminar flow hoods at full capacity
20,000 Units/Day
Maximum daily syringe output
8,000 Bags/Day
Maximum daily IV bag output
2 ISO 7 Cleanrooms
Second suite currently being commissioned
1 ISO 8 Suite
Dedicated API dispensing environment
48-Hour Turnaround
Standard lead time for most products
48 States
Licensed to ship to 48 states (excluding Alabama and California)
Est. 2020
Purpose-built facility, Houston TX
Excellence in 503B Outsourcing
When It Matters Most
Facility Overview
Opened in May 2020 and continuously upgraded since, our Houston facility was designed with one goal: to be a sterile compounding partner for healthcare systems in Texas and beyond. From raw material intake through final shipment, every square foot of our facility has been designed to support compliance, and process consistency.
Our facility holds FDA 503B registration, DEA registration, and operates in full compliance with current Good Manufacturing Practices (cGMP) and USP <797> standards. Each operational area, from our ISO-classified cleanrooms to our quality control suite, is purpose-built to support high-volume, high-complexity sterile manufacturing.
Centrally located within the Texas Medical Center corridor, Wells Pharma benefits from direct proximity to some of the most sophisticated hospital systems in the country, while our nationwide shipping network ensures timely delivery to most U.S. states.
Cleanroom Infrastructure
Controlled environments designed for sterile manufacturing
Our cleanroom infrastructure is the backbone of everything we produce. All sterile products are manufactured in rigorously maintained, ISO-classified environments with continuous environmental monitoring operating 24 hours a day, 7 days a week, 365 days a year.
ISO 7 Cleanroom : Suite 1 (Operational)
Our primary ISO 7 cleanroom houses 10 vertical laminar flow hoods operating within ISO-5 classified environments. This suite supports the full range of our current parenteral product portfolio, with validated processes and continuous environmental monitoring data trending.
ISO 7 Cleanroom : Suite 2 (Coming Online)
Our second ISO 7 cleanroom is currently being commissioned, adding 14 additional vertical laminar flow hoods , more than doubling our total hood count from 10 to 24. This expansion directly translates to greater production capacity, more product availability, and reduced lead times for our partners.
ISO 8 API Dispensing Suite
A dedicated ISO 8 Active Pharmaceutical Ingredient suite provides a controlled, classified environment for the weighing and dispensing of bulk APIs before they enter the compounding workflow. This separation ensures cross-contamination controls are robust from the start of every batch.
24/7 Environmental Monitoring
Continuous environmental monitoring across all classified spaces ensures that our cleanrooms maintain particle counts, differential pressures, temperature, and humidity within validated ranges, around the clock, every day of the year. All environmental monitoring data is trended for regulatory compliance and operational insight.
Production Capacity
High-volume output with room to grow
Our current production infrastructure supports significant daily output, with additional capacity already being commissioned as our second cleanroom suite comes online.
- Up to 20,000 syringes per day
- Up to 8,000 IV bags per day
- 10 ISO-5 vertical laminar flow hoods currently operational
- 14 additional hoods being commissioned , bringing total capacity to 24 hoods
- Most products available to ship within 48 hours of order
Automation & Equipment
Technology-informed manufacturing approach
Wells Pharma continues to evaluate and implement technologies that support consistent, scalable manufacturing processes. As part of our ongoing operational development, we assess equipment and workflow enhancements that may help support controlled production environments, process standardization, and evolving customer demand. Several systems are currently being onboarded as part of ongoing efforts to evaluate manufacturing processes and technologies.
Current and planned automation initiatives include:
- Automated Syringe Filling (In Development)
An automated syringe filling system is currently in development as part of our broader effort to expand infrastructure supporting sterile manufacturing workflows and technologies. - Semi-Automated Vial Crimping (In Development)
A semi-automated crimping solution is in development for integration into vial-format workflows as part of our continued investment in production infrastructure. - RFID Label Scanning (In Development)
An RFID-enabled label scanning process is in development to support internal workflow verification and product identification throughout various stages of production and distribution.
Note: this system functions as a workflow-integrated label reader and is not an automated labeling machine. - Homogenization Systems
Homogenization technology is utilized where formulation requirements call for controlled mixing processes as part of standard compounding practices.
From Raw Material to Release: Every Step by Design
Incoming APIs and components are inspected against internal specifications. Certificate of Analysis (COA) documentation is reviewed and verified before any material is released into production. All items are logged and tracked through the quality management system.
APIs are weighed and dispensed in a dedicated ISO 8 suite, maintaining appropriate contamination controls before materials enter the cleanroom environment.
All materials and components undergo sanitization and decontamination using approved cleaning agents before entering ISO 7 classified cleanrooms, in full compliance with USP <797> requirements.
All sterile products are manufactured within ISO-5 vertical laminar flow hoods located inside ISO 7 cleanrooms. Qualified, trained compounding personnel follow validated batch records at every step, with complete documentation throughout.
Every batch undergoes 100% visual inspection by qualified manufacturing personnel. Acceptance Quality Limit (AQL) inspection is conducted on-site by quality control staff to verify closure integrity, label accuracy, and absence of visible particulates.
All batches are submitted to qualified, accredited third-party laboratories for release testing. Testing includes potency, sterility, endotoxin, particulate matter, and pH as applicable to each formulation and container type.
Products are labeled using RFID-enabled automated systems in accordance with ASTM, DQSA, and ISMP medication labeling standards. Barcode scanning at multiple fulfillment checkpoints ensures every order is verified before shipment.
Wells Pharma ships to 48 states, with most products available within 48 hours of order. Temperature-sensitive products are shipped in validated cold-chain packaging to ensure integrity from our facility to the pharmacy door. (Note: Wells Pharma does not currently ship to Alabama or California.)
Quality Assurance
Quality is not a checkpoint – it is built into every step
At Wells Pharma, quality assurance is embedded throughout the manufacturing lifecycle, not applied at the end. Every batch produced in our facility is subject to a comprehensive set of controls designed to support quality and align with regulatory requirements.
- 100% visual inspection of every batch by qualified personnel
- On-site Acceptance Quality Limit (AQL) sampling by dedicated quality control staff
- Third-party release testing through qualified, accredited laboratories (potency, sterility, endotoxin, particulate matter, pH)
- 24/7/365 continuous environmental monitoring across all ISO-classified spaces
- Validated batch records and equipment qualification maintained for every product
- Full documentation and traceability from raw material intake to final shipment
Product Portfolio
Parenteral preparations supporting the full perioperative spectrum
Wells Pharma compounds a focused formulary of high-demand, medications, all manufactured as sterile parenteral preparations, except for Indomethacin, which is available as a suppository. Our portfolio is purpose-built to support hospital pharmacies and surgery centers with attention to supply considerations.
Why Houston
Strategically Located in the Heart of the Texas Medical Center
Our Kirby Drive facility sits within one of the largest medical complexes in the world, the Texas Medical Center, giving Wells Pharma direct proximity to some of the most sophisticated hospital systems in the country. Combined with our shipping network reaching 48 states, Houston’s central position in the Gulf Coast corridor supports distribution to healthcare facilities across the South, Southeast, and beyond.
Contact us for more information, and visit our sing-up page for hospitals & surgery clinics.
Deliver Consistently.
Wells Pharma of Houston.
Your Trusted 503B Partner in Patient Care
We’re passionate about service and dedicated to supporting patient-first care. Let’s connect today to discuss how we can meet your 503B outsourcing needs.
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