The Future of Contract Manufacturing for the Pharmaceutical Industry
Pharmaceutical companies have grappled with the challenge of maintaining robust financial performance to meet escalating demand. This is especially true when acquiring and operating costly equipment for large-scale drug production. To address this issue, numerous enterprises have opted to contract out their manufacturing processes to Contract Manufacturers. These specialized manufacturers possess the essential equipment, infrastructure, and workforce to create products at a reduced expense. This form of outsourcing has become a groundbreaking strategy in the ongoing pursuit of more affordable healthcare services in the modern era.
Formulation
1. Active Pharmaceutical Ingredient (API) solubility testing
2. Blending of formulation components using high/low shear homogenizer
3. Coating of blend using casting knife on a release liner
4. Lamination of coated film with backing
5. Die cutting of laminate
6. Pouching of the die cuts in pouch material
7. Stability testing of the final product
Analytical
Method development, transfer, verification, & validation
In-Process testing on blends and laminates
Final product release testing
ICH Stability storage and testing
Microscopy capabilities
Controlled substance storage and handling
Cleaning methods
Compendial raw material testing
HPLC and GC (Empower 3 Software)
TOC, Karl Fischer moisture, Instron, viscosity, texture analyzer
Dissolution apparatus (App 1,2,5,6,7) equipped with autosamplers
Blending
The first step is to determine the batch size, select the mixer, and calibrate all blending equipment.
The preliminary blending process is then defined, and the vessels for pre-mixes are chosen.
We begin blending the batch after we have established the blending parameters.
Because quality is so important to us, we sample our blends at every stage of the process.
We conclude with a final quality check.
Our approach is the most effective in the industry.
Coating
Introduce the blend to establish parameters for the coating temperature, line speed, and thickness
Meter the blend onto the polymer liner
The wet-blend liner goes into the state-of-the-art ovens
Finished laminate is wound and prepared for the next step
Conversion
Gather materials from order specifications
Perform a material quality check
Set converting line for the project's parameters
The line goes through the centering process, ensuring accuracy
Converting process starts running — during this step, we continually conduct in-line process and quality checks
Upon job completion, the production record is reviewed following our documentation practices
Final release testing occurs, followed by packaging and shipping
Packaging
We provide customized packaging solutions based on the requirements of each client.
Our in-house capabilities allow us to provide the most efficient packaging solution while saving you time and money.
Our services range from manual packaging to fully automated, high-speed cartoning.
We can complete primary packaging on the converting line thanks to our cutting-edge equipment.
In addition, we have the capacity to serialize and process hundreds of millions of finished parts per year.
Carense's breadth and depth of experience over the years has led to us being pharmaceutical packaging experts.
To produce an exceptional final product, we ensure quality at every step of the way.
Serialization
Configure connection from line-level machinery through L4 provider database to customer and final product shipping location
Perform batches in the test environment to ensure serial numbers and batch reports transfer correctly
Validate all serialization and aggregation of test batches and the communication through all the systems
Begin commercial production with saleable product
Shipment
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