Aseptic Manufacturing

About Nova-Tech’s Aseptic Manufacturing Process

Whether your project is a liquid small volume parenteral (SVP) or a large volume parenteral (LVP), you can rely on Nova-Tech for expertise in the development, optimization and scale-up of complex formulations. Our 28 years of experience span a significant number of projects and a wide variety of animal pharmaceuticals, and we have the resources, technology and container variety to deliver the perfect solution for virtually any aseptic fill project.

Our facility is designed and operates under Current Good Manufacturing Practice (CGMP) standards and offers clients the advantage of an established infrastructure and deep experience base combined with the flexibility to meet customer needs in a timely fashion.

 
 
 
 
 
Step1

Step 1 – Design, Formulation, Scale-up

Our facility provides small- to large-scale aseptic processing as well as expertise in everything from protocol design to scale-up manufacturing. We bring quality to every step of the process, ensuring consistent delivery of a quality drug product by way of thorough planning, execution and completion.

We assess the suitability of each manufacturing step as it relates to the overall manufacturing process and perform controlled bench-top studies to confirm our results. This ensures a successful program from design to scale-up.

 

Step2

Step 2 – Compounding

Nova-Tech is capable of producing batch sizes as small as 850 liters to 24,000 liters. The following reflects our current capabilities. Our unique approach to meeting individual client needs includes installation of new equipment as needed. If we cannot accommodate your requirements, we pledge to work with you to create the means to do so.


Compounding Suite A

  • 640 square feet
  • Up to 24,000 liter batch compounding capacity
  • Load cells
  • Variable speed mixing system  
 

Compounding Suite B

  • 640 square feet
  • Up to 15,000 liter batch compounding capacity
  • Load cells
  • Variable speed mixing system 
Step3

Step 3 – Aseptic Fill

In aseptic fill, Nova-Tech offers aqueous-based aseptic injectables as SVP or LVP nutritional vitamins and minerals.  Our cleanrooms provide sterile manufacturing utilizing two CGMP level 100 filling suites. Product is sterile-filtered through two 0.2 micron filters, dispensed into sterile containers and sealed.


Line A

  • ISO Class 5 filling areas with cascade classified support
  • 8-head filler
  • 250mL-1000mL fills
  • Stopper inserting system
  • Plastic containers
  • Variable fill speed
 

Line B

  • ISO Class 5 filling areas with cascade classified support
  • 6-head filler
  • 100mL-500mL fills
  • Stopper inserting system
  • Plastic and glass containers
  • Variable fill speed
Step4

Step 4 – Packaging and Labeling

Two On-line/Off-line Packaging Lines

  • Automatic capper/crimper
  • In-line check/weigh
  • Labelers controllable for container size, type and line speed
  • Inkjet printer
  • Manual pack-off gives flexibility for custom packaging requirements
  • Off-line label preparation includes bar-code and thermo label options

 

 

Step5

Step 5 – Quality Management

Quality is the foundation of our business. Utilizing a highly trained and motivated staff working within a deeply embedded quality system, our aim is to provide the finest quality products in a time frame that meets customers’ needs.


Laboratory Control
Nova-Tech’s on-site laboratory provides fast, accurate results for routine component, in-process control, finished drug product and stability testing. Capabilities include:

  • Sterility testing
  • Endotoxin testing
  • USP identification and assays
  • Air and liquid particle counts
  • UV/Vis spectrometry
  • Water analysis
  • Incubation chambers with controlled variable conditions

In addition, our contract laboratory partners provide full support including method development, method validation and routine testing for all levels of compliance.

  Quality System
Continuous improvement is fundamental to how we operate, and we are always looking for tools and techniques that can help us develop systems and train personnel throughout our entire process. To ensure consistent quality, we create a master validation plan that includes system design, equipment qualification, process validation and change control throughout the life cycle of a product or process. Other Nova-Tech quality control services include:

  • Full documentation
  • Vendor qualification
  • Annual product review
  • Customized stability programs
  • Method development and validation
  • Product, technology and method site transfer
  • SPL submission of labeler code, establishment registration and drug listing
  • Technical support
  • Project management
Step6

Step 6 – Warehousing and Shipping

We have five warehouses for storage. Finished products are stored in designated locations; temperatures are monitored and tracked within the building management system.  Manufactured products are clearly identified using a quarantine system and a release system upon approval from laboratory control.  

Nova-Tech has a Bright Stock inventory program that allows the customer to receive products in a much shorter amount of time. Upon release by laboratory control, the products are shipped per client’s request.

Products manufactured by Nova-Tech are distributed throughout the U.S. and Canada.

Warehouse 1: 10,700 square feet

Warehouse 2:   3,700 square feet

Warehouse 3: 10,000 square feet

Warehouse 4: 10,000 square feet

Warehouse 5:  20,000 square feet