Parenteral Drug Processing Precision
Parenteral drug production is often complex and challenging and requires a precision mindset. Pii's fill-finish, lyophilization, and formulation teams of scientific experts work with you throughout all stages of drug development, providing a quality product while mitigating risks and preventing costly delays.
PARENTERAL DRUG FORMULATION, PROCESS DEVELOPMENT & FILL-FINISH IN VIALS, SYRINGES AND CARTRIDGES
Parenteral Drugs, Biologics and DEA-Controlled Substances
Pii enables biotech and pharmaceutical companies to accelerate timelines to get products into the clinic on time and within budget. Our proven capabilities include aseptic fill-finish, terminal sterilization, and lyophilization of biologics, small molecules, potent compounds (HPAPI) up to SafeBridge® Category 4, DEA substances, hormones, and cytotoxic drugs. Our four filling lines offer the flexibility to fill small clinical up to larger scale commercial batches into vials, syringes, and cartridges.
A key focus is on accelerating decision-making at every step of the drug development process using QbD to meet your expected targeted product profile and project milestones. With four filling lines, we can provide rapid access to manufacturing slots, coupled with timely analytical release of your drug product, for clinical trial or commercial supply. All parenteral products are processed and tested in strict accordance with GMP requirements and our facilities are FDA and DEA inspected. Services include:
- Development and product of injectable dosage forms
- Lyophilized product development and GMP scale-up and manufacturing
- Complex dosage forms, including suspensions and highly viscous liquids
- Production of long-acting and depot injectables
- Fill-finish into vials, syringes, and cartridges
- Aseptic filtration and terminal sterilization processes
- Lyophilization services of drugs, proteins, and biologics in vials (3mL to 50mL)
Learn more about Pii’s Lyophilization Services
PARENTERAL DOSAGE FORMS
Precision Parenteral Drug Processing
The stakes are high! 100,000 doses of a modern parenteral drug formulation can cost millions. With patient populations whose lives depend on quality injectables delivered on time, there is simply no room for anything less than perfect.
Our skilled, experienced team of professionals employing the precision capabilities of Bosch filling systems will efficiently complete your project with efficiency, on time, and with the highest quality standards.
Request the aseptic capabilities fact sheet below
Specialized Parenteral Capabilities and Equipment
State-of-the-art GENiSYS®R
The State-of-the-art GENiSYS®R Robotic line is ideally suited for or small batch filling and closure. Features include:
- Fully robotic, RABS automated line that eliminates human intervention
- Pre-qualified – no additional costs for media fill qualification
- Customized statistical in-process controls (IPC) for complete, real-time batch records
- Multiple container options – vials, syringes, cartridges
- Accurate precision-filling that eliminates the loss of costly drug product
- Continuous, non-destructive weight testing – no stoppages or wasted materials
- Pre-sterilized vials and syringes on-hand to support shortened timelines
- Adaptable RABS – flexibly protecting your product and production workers
- Rapid production line change-over, up to 2 batches per day, accommodates multiple container-closure sizes, perfect for supporting Phase 1 clinical studies
GENiSYS®R Robotic Aseptic Fill-Finish Video
Bosch Vial Filling Line
For larger scale batch requirements, Pii can support technical transfers and commercial production, using the Bosch vial filling line:
- Completely integrated system from vial preparation to filling and capping
- Flexible design for customized batch processes
- Superb engineering for continuous production
- Support both aqueous and non-aqueous formulations
- Large batches with single-use compounding vessels up to 1,000 liters
- Aseptic filtration or terminal sterilization processing
- Vial sizes of 2mL up to 100mL
Bosch Vial Filling Video
View Our Development and Clinical/Commercial Drug Product Manufacturing Facility Facts
M&O Aseptic Vial Filling Line
Flexibility for customers is what makes Pii’s M&O Perry aseptic vial filling line unique. Features include:
- Ability to fill up to 40 vials per minute
- Support batch sizes up to a 500-liters
- Ability to fill a vial sizes range from 3mL to 100mL
- Enables vials to be aseptically filled, lyophilized, or terminally sterilized
- Supports single-use, disposable technology, glass carboys, and stainless steel for compounding needs in the Class “C” environment as well as receiving containers inside the Class “A” environment
- Supports both peristaltic and rotary piston pumps for filling accuracy
- Provides flexibility on container and closure systems
- Two filling heads that can be fitted with stainless steel or single-use disposable needles
- A third needle can support inert gassing requirements such as nitrogen overlay for products that are sensitive to atmospheric headspace prior to the stoppering station
- Accommodate a variety of stopper sizes for filled vials from 3 milliliters with a 13 millimeter neck-finish up to a 100 milliliters with a 32 millimeter neck-finish
- Scalable solution for customers seeking clinical manufacturing, as well as small- to large-scale manufacturing requirements
M&O Aseptic Vial Filling Line Video
Groninger Pre-filled Syringe Line
Pii’s Groninger syringe line supports batch sizes up to 50,000 syringes per day with pre-filled syringe sizes ranging from 1mL through 5mL. No matter the processing and formulation complexities, Pii and its Groninger Syringe Line can assist with your sterile fill-finish manufacturing. The Groninger pre-filled syringe line supports:
- Ready-to-use pre-filled syringes that come in nested tubs, as well as plungers
- Qualified sterilization processes for components being used in the production process
- Two-headed filler with inert gassing capabilities under Grade “A” HEPA filtered conditions
- Rotary Piston Pumps that support filling of variety of products, including highly viscous formulations
- Programs from development through commercialization
