Questions You Should Know about Wet Process Equipment Manufacturer

Author: Shirley

Dec. 16, 2024

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Tags: Machinery

CPS | Top 7 Customer Questions About Wet Milling for ...

The ability to produce extremely fine particles is essential for pharmaceutical manufacturers.

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But achieving these fine particle sizes, whether in a micronization or nanonization size range, requires more than just the right types of milling equipment. It also takes expertise.

In a wet media milling process, the raw feed material particles, typically 200 microns or smaller, are suspended in a liquid slurry and forced through a milling chamber that has been charged with milling media by a high-speed agitator shaft. 

The suspended particles are recirculated until the target particle size has been met, which can require adjustments to the media size or material, agitator speed, product flow rate, slurry liquid-to-solid ratio, and time on the mill.

But a process that may seem simple can be surprisingly complex, especially when it comes to products meant for human consumption and the particle precision needed for pharmaceuticals.

That&#;s why manufacturers often have questions for their contract processors &#; and why the answers are so important.

Why Do Pharma Manufacturers Require Wet Milling Services?

Particles in the sub-micron ranges can have distinctly different material characteristics from larger particles of the same material. The differences can deliver numerous benefits to a manufacturer, including:

    • Controlling costs by using less of expensive active pharmaceutical ingredients
  • Reducing unwanted side effects
  • Offering more varied alternatives for administering medication, including oral, transdermal, inhalation, parenteral, injectable, etc.

These are just a few reasons pharmaceutical manufacturers need to know they can trust their wet milling services providers to perform processing techniques exactly as they say they do.

Another important benefit of wet milling is safety. Dry milling methods such as jet milling can often achieve the desired particle size, but some materials can pose a risk to personnel &#; even with proper handling and personal protective equipment (PPE). In wet grinding, the raw feed material is suspended in a liquid slurry and recirculated in a closed-loop system, eliminating the production of dust.

Notably, that closed-loop also means lower yield loss on wet milling compared against dry methods like jet milling. And, the liquid slurry used in wet media milling can also act as a heat sink, protecting the material from fast-rising temperatures in processing. With all these benefits, it&#;s no surprise that wet milling is in high demand.

What Do Pharma Companies Need to Know About Wet Milling?

When pharmaceutical manufacturers come to CPS with milling projects, there are certain assurances they look for &#; and with good reason. Any company outsourcing critical processes to a third party should be able to trust that they&#;ll achieve the same level of quality or better from their contract manufacturing partner.

Here are some of the most important considerations that we most often discuss with customers in pharmaceuticals&#;and these questions often also apply to customers in food and beverage, nutraceuticals, and many other industry verticals:

1. HACCP Plans

A Hazard Analysis and Critical Control Point (HACCP) plan is essential for identifying, monitoring, and addressing hazards to the product throughout processing. Pharma customers should expect their processing experts to be well-versed in HACCP principles, and able to produce a HACCP plan for any process to mitigate risks of contamination or product degradation.

2. Validation of Cleaning Procedures

Cleaning validations establish documented procedures with evidence that the cleaning methods effectively remove contaminants to prevent cross contamination. This is especially important when working with a toll processor to protect product purity, as well as to ensure batch-to-batch segregation and control. 

A toll processor should be able to develop, test, and validate repeatable cleaning protocols for customers. In fact, disciplined, controlled cleaning procedures are as important as documented processing protocols for ensuring product quality, purity, and safety.

3. Temperature Control Capabilities on Wet Milling Equipment

The very nature of the process of attrition &#; the grinding down of particles that takes place inside the wet mill &#; can cause friction, which in turn can increase the material&#;s temperature.

Depending on the product, heat can cause concern for safety, quality, or product degradation. That&#;s why it&#;s important to inquire about a milling service provider&#;s ability to chill the slurry during mill operation.

4. Health & Safety Assurances

Pharmaceutical companies are in the business of health. Safety and health of the personnel needed to make their products is absolutely essential. Workers&#; eyes, skin, lungs, and hands must be kept safe throughout every phase of work. 

Detailed safety protocols should be part of every processing step, and should include PPE specifics like respirators, safety eyewear, apparel, gloves, and other items. Customers should be able to verify correct use of all PPE as described in process steps.

But long before the question of process steps and PPE arises, customers should expect to provide Safety Data Sheets (SDS) for the raw material and final product, for review by the toll processing team&#;s Environmental Health & Safety manager.

5. Quality Systems & Certifications

Questions about quality systems, accreditations, and certifications are often an early step in establishing a vendor relationship with a trusted tolling partner. Pharma customers should expect their contract processor to be able to demonstrate Food Safety System Certification (FSSC ) accreditation, Current Good Manufacturing Practices (CGMP) certification, and the ability to provide kosher, organic, and halal certifications for products processed in their facilities.

In addition to these certifications, many pharmaceutical manufacturers perform their own audits and inspections for their vendor qualification programs. Your milling services provider should welcome the opportunity.

6. Shipping & Receiving Details

Materials destined for wet milling are often shipped in a dry, pre-milled state, often in bulk formats like super sacks or drums. But in other cases, customers provide the raw feed already added to an appropriate suspension liquid. Either way, it&#;s critical to know that a processor is equipped and ready to handle the product in your preferred format, and that as a customer, you understand the details of shipping and receiving.

7. Other Critical Services for Pharma Customers

Pharmaceutical customers might be surprised to find the range of services available at a single toll processing facility. While you might initially be looking for wet media milling services, future needs could call for jet milling, blending, liquid bottle filling, or a straightforward repackaging project to keep things moving smoothly through your own production facilities. 

As a customer, you should never hesitate to ask questions. Your toll processing team&#;s technical sales engineer is there to answer them and provide all the assurances you need to have total confidence in the quality of your product.

If you are looking for more details, kindly visit JYN.

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Learn more about working with a specialized, CGMP-certified toll processor for particle size reduction when you download our guide, Milling Methods for Food and Pharma. Click below to claim your copy now.

5 Things to Look for in a Wet Bench

When it comes to choosing a wet bench, safety and quality are key. It is important to choose a vendor and equipment that abide by the Factory Mutual Research Corporation (FMRC) guidelines.

How do you choose from all the various models out there? Keep reading to learn about the top five things to consider for wet process equipment.

1. High-Quality Control Standards

Ensuring the wet bench meets high-quality control standards to prevent hazards and fire is the most important thing to look for when choosing a product. When purchasing or looking to retrofit, be clear that the product specifies that it is up-to-date on the most recent controls standards.

Look for equipment that guarantees it meets FMRC codes, including UL and FM standards. These protocols are not only for manufacturing equipment but are also being adopted by building codes.

2. Meets Your Direct Needs

Select a wet bench model that has equipment designed for your needs in mind. Determine if you need fully-automated, semi-automated or manual equipment.

Consider what chemists and process engineers will come in contact with at the wet bench. From there, you can decide which fire-safe plastics should be used. Look for materials that are long-lasting as well as compatible.

Another thing to consider is the environment of the bench. Where will it be located and how much wear and tear will it receive?

If the equipment will be exposed to harsh manufacturing or construction settings, then you will need a bench that is durable and corrosion-resistant.

If you cannot find one that is particular to your project, then go with custom fabrication options. Also, be sure to choose equipment that includes custom installation, on-site repairs, and 24/7 tech support.

3. Fits Your Budget

Consider your budget before you begin shopping. Different types of materials cost different amounts.

Calculate that the plastic sheet should take up approximately 15% to 30% of the total cost of the wet bench.

If you need multiple benches, this can be cost-effective. Multiple purchases or designs can get you a discount if ordered at the same time.

Make sure safety concerns line up with your budget requirements.

4. Offers Turn-Key Solutions

Choose a wet bench supplier that is a one-stop shop and offers turn-key solutions and systems integration. You will be glad you did in the long run.

Purchase your equipment from a vendor that not only provides the wet bench, but also includes repairs, installations, tech support, OEM warranty support, and updates as your needs change.

Verify they are up-to-date with control standards and compliance and have extensive knowledge of fire-safety material. Important electrical codes certifications include CE, UL, NEC, and NFPA.

5. Positive Reputation and Expertise

You should also look for a vendor that has an established positive reputation. Find a company that is known for their relationships and continual support. This will come in handy if things go wrong in the future.

Lastly, choose a vendor that has years of experience. This will ensure they have the finances and expertise to provide top-notch equipment and services. You want to be able to call on your vendor and easily get the answers to your questions.

Ready to Order?

At Superior Automation, we provide state-of-the-art wet processing equipment that provides high-quality automation, technology, and personalization.

We can custom design our equipment to fully fit your needs. Plus, when you order from us you obtain a relationship for life. We include system integration, upgrades, retrofitting, and support.

Check out all of our wet bench products today.

Established in , Superior Automation provides cutting-edge automation solutions for customers around the globe, ensuring quality control and meeting industry safety and compliance standards.

Are you interested in learning more about Wet Process Equipment Manufacturer? Contact us today to secure an expert consultation!

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