Sterile Manufacturing

Overview

As a leader in sterile filling, our manufacturing processes are flexible, scalable and proven over decades of service to our animal health clientele.

In spite of significant changes in the animal health supply chain, Nova-Tech remains a constant in a market heavily influenced by regulatory demands and commodity pressures. Our continual investment in equipment and facilities is a clear indication of our intent to remain at the vanguard of sterile manufacturing for the animal health industry.

Our experience spans decades and includes a wide variety of animal pharmaceuticals from liquid Small Volume Parenterals (SVP) to Large Volume Parenterals (LVP). Regardless of the product, the packaging or the scale of the project, Nova-Tech adheres to strict process protocols including pre-production planning, documentation, laboratory analysis, supply chain management and quality control at every step.

STEP 1

Design, Formulation, Scale-Up

Getting you the animal health product you need with the absolute assurance of quality and consistency is our ultimate goal. It starts well before we start filling the first vial or bottle. Every manufacturing project large or small begins with an overall project design and plan. You’re a part of that process as we align and customize our processes and protocols at each step, including bench-top studies, controlled engineering and scale-up batches.

STEP 2

Compounding

By offering batch sizes from 500 liters all the way up to 24,000 liters, Nova-Tech can accommodate a wide range of product manufacturing. With multiple compounding suites, each with variable speed mixing systems, we are well equipped to meet a wide variety of customer requirements. Our compounding process is temperature controlled between 15°C and 75°C, with the option of jacketed tanks and nitrogen overlay.

At Nova-Tech, we are continually assessing our in-house capabilities to ensure our equipment and processes align with advancements in the industry and the demands of our customers.

STEP 3

Aseptic Fill

Nova-Tech is an expert at manufacturing aqueous-based aseptic injectables of Small Volume Parenterals (SVP) or Large Volume Parenterals (LVP). Product is filtered, dispensed into sterile containers and sealed. Our cleanrooms provide sterile manufacturing in ISO Class 5 filling suites. We can provide both ambient fill and nitrogen overlay processes.

ISO Class 5 filling areas with cascade classified support
80mL-1000mL fills
Stopper inserting system
Plastic and glass containers
Variable fill speed
Optional nitrogen overlay

STEP 4

Packaging & Labeling

We have on-line/off-line packaging lines, each with automatic capper/crimper capability and in-line check-weighing. Labelers are adjustable for container size, container type, line speed and bar code options. We also offer manual packaging to meet the special demands of custom products.

STEP 5

Laboratory Control

Our on-site laboratory, staffed with highly-trained technicians, provides fast and accurate analysis at all stages. Our laboratory capabilities include:

Sterility testing
Endotoxin testing
USP identification and assays
HPLC analysis
ICP-OES analysis
Air and liquid particle counts
UV/Vis spectrometry
Water analysis
ICH-compliant incubation chambers with controlled variable conditions

We also contract with highly-qualified laboratory partners to provide additional support including method development, method validation, stopper puncture studies, in-use stability, filter validation, and routine testing for all levels of compliance.

STEP 6

Warehousing & Shipping

Nova-Tech has a total of more than 54,000 sq. ft. of temperature-monitored storage. Finished products are stored in designated locations and clearly identified using a quarantine-approved release system. Once products are released by our quality control team, they are shipped based on the customer’s requirements.