3 Critical Things to Know About the Blending Process in the Pharmaceutical Industry
by Carl Fiorini, on Feb 6, 2020 8:00:00 AM
A perfectly homogenized product: That’s the goal of every blend.
Many industries rely heavily on mixing and blending technology to create products. Within some of those products, blending various particulate ingredients is easy. In other industries, such as pharmaceuticals, it’s not always so simple. Typically in the pharmaceutical industry, small amounts of an active drug are exactly blended with excipients, the non-active ingredients, such as cellulose, lactose, starch, or lubricants. Excipients that are stickier than the active ingredient are harder to effectively blend, and a significant difference in their sizes can cause segregation of the ingredients.
This article will cover the three most critical aspects you must know when it comes to the blending process in the pharmaceutical industry:
- Process control
Process Control is as Vital as Blending Itself
Toll blenders experienced in pharmaceutical blending know that becoming supplier qualified is a more difficult process (and much more time-consuming) than actual blending.
Typically, a company that blends must become an approved supplier for each customer’s particular needs. Perhaps the most demanding industry for blending, pharmaceutical blending includes a high amount of paperwork for traceability, due diligence, and audits.
A customer audit not only includes documenting the toll blender’s cleaning programs, practices, and blending processes, it covers a full exploration of the upstream/downstream of materials; where each one is from and where/how they’re transported after blending.
Overall, qualification is a comprehensive, time-consuming process. Full qualification, including all documentation and the customer audit, could take from 3 months up to 1 year.
In addition to time constraints, a vital part of process control is running process validation and equipment qualification batches. Unique protocols are written to run test batches, ensuring that the same processes result in the same quality coming out of the blender every time.
Just as in any industry, experience has its advantages for toll blenders. Years of blending various materials, tackling different challenges, and completing many qualifications makes the next qualification quicker and less stressful.
Cleanliness Cannot be Compromised … Ever
Toll processors are, by nature, focused on cleanliness. This is enhanced to obsessiveness for the pharmaceutical industry where quality is obviously paramount. Simply put, proper toll blending is counted on to assure quality.
A clean room with all surfaces sanitized is the core of a well-prepared blending environment in pharma. Equipment contamination, both microbiological and from previous materials, is avoided using multi-level cleaning programs based on industry requirements for that material.
In general within blending, grade levels include food grade, technical grade, pharma grade, allergen grade, and others. The FDA’s regulatory standard for pharma is the Current Good Manufacturing Practice (cGMP) regulation for human pharmaceuticals.
Adhering to cGMP regulations maintains the quality, strength, and purity of drug products. Controlling every step of manufacturing operations ensures that the manufacturers of medications deliver safe and trusted products.
Plus, formal documentation is required to prove blend uniformity. Samples are extracted from batches and checked against specifications. No other industry is as strict with cleanliness and testing as the pharmaceutical industry.
Equipment Selection Importance Cannot be Overstated
Historically, the blending process has been the bottleneck of manufacturing operations. Because industrial blending equipment cannot be filled or emptied until active mixing has been completed, it involves multiple processes during which no other task can be done.
This inherently puts pressure on having the correct blending equipment to precisely combine ingredients to achieve the exact blend … and in a timely manner.
Choosing a blender depends on the particle size, shape, and density of the excipient and active ingredients. The correct blender needs to be selected for the material, which could be a ribbon blender, paddle blender, continuous blender, tumble blender, or vertical cone blender.
For most pharma products, a double-ribbon blender’s low shear provides homogenization, consistency, and accuracy that ensures a safe, pure, and effective end product. Yet it’s not uncommon to use a number of different blender styles to process and prepare a finished pharma product.
The blending process has a huge influence on a drug’s ability to deliver an accurate dosage, look appealing, and remain stable.
Choosing the Right Toll Processor for Pharma Blending
An easy way to begin evaluating a toll blender is to just look at the three critical aspects of the blending process for pharma. Yet, you should dig a little deeper.
When it comes to equipment, the obvious asks are capacity (from as little as a few dozen liters up to multiple metric tons is a good range) and ease handling cellulose-based material (specifically organic pulp fiber).
Also any reputable blending professional utilizes different types of packaging (super sacks, drums, bags, etc.). Other capabilities may include temperature adjustment (adding heat) and process flexibility (spraying oil onto dry powder to coat particles within a blender, for instance).
Look for an entire and complete technical sales team of three to five people to work with your quality department. That crew usually consists of a technical sales engineer, food safety and pharma manager, quality control pro, and production manager.
The key is having a comprehensive look at the process as well as being comfortable navigating the process supplier approval and audit processes. And even though most customers usually come to a blending company with a formula in mind, having formulation experience and insight can provide guidance (related to excipients, for instance).
The blending process in the pharmaceutical industry has always been challenging. If the active and excipient ingredients aren’t adequately blended, uniformity is affected, the product won’t perform properly, and the brand’s image suffers.
An experienced toll blender brings mixing experience with many materials within a variety of industries to create your perfectly homogenized product. Connect with CPS, the Architects of What’s Possible, to discuss your unique needs.