Contract Manufacturing

The COVID-19 outbreak prompted a significant surge in the pharmaceutical sector's utilization of contract manufacturing. The industry's remarkable growth is evident in its rise from $934.8 billion in 2017 to $1.17 trillion in 2021, indicating exponential expansion. These figures might actually underestimate the true extent of growth, considering the elevated global emphasis on improved healthcare starting in 2020.

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.

Our formulation process has been informed over years of experience and knowledge within the business. Below is a sample of our pharmaceutical formulation process at Carense Pharmaceutical ®.
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

Our analytical lab is staffed with experts and robustly equipped to meet your needs. Below is a summary of our analytical capabilities.

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

It is critical in the pharmaceutical blending process to obtain a stable and consistent mixture without altering the drug.
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.

We use our experience, knowledge, and equipment to create the most efficient process for our clients. With the ability to perform both slot die and comma head coating, we use a typical comma head coating set-up for solvent-based systems, and a slot die coating set-up for water-based systems. Below is a sample, high-level pharmaceutical coating process at Carense Pharmaceutical ®.

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

Carense Pharmaceutical ® has been converting pharmaceuticals ever since its formation. Decades of team experience has enabled us to master the converting processes and become leaders in the industry. We offer fully customizable converting lines to meet our clients' needs. The adaptability and accuracy of our converting lines ensure the final goods meet each client's exact specifications. Below is a sample step-by-step converting process at Carense Pharmaceutical ®.

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

Carense Pharmaceutical ® places a premium on customer satisfaction and product quality.
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.

At Carense Pharmaceutical ®, we are able to guide products through the necessary steps to develop, test, validate, and approve a process for serializing a pharmaceutical product in a reliable manner. We have full vision inspection on the lot code information and bar code data. Each product is scanned and verified upon aggregation to ensure accuracy. Below is a typical step-by-step serialization process at Carense Pharmaceutical ®.

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

Carense Pharmaceutical ® takes great pride in ensuring that our clients' products arrive in excellent condition. The best thing about our shipping is that we can completely customize the process for our customers. We will listen to each and every client request and design our pharmaceutical shipping process around those requests. Everything will be aligned to best suit our clients and their product. We are always on time !