Frequently Asked Questions ACM Study

The following are frequently asked questions regarding application cleaning methodology testing.

OVERVIEW

What does ACM stand for?

Application Cleaning Methodolgy

What is an ACM study?

An Application cleaning methodology study starts with a simulation of your cleaning process to optimize and target the residues you are trying to clean. This replication of your process conditions allows for the most reliable and accurate cleaning recommendations. 

 

How do I initiate an ACM Study?

Fill out this form and submit it to the Chematic Lab.

Do I need to submit samples of my product when initiating my ACM Study?

Yes. The Chematic lab will need 500g of your final formulation to complete the necessary cleaning evaluation.

PROCESS

How is an ACM study Accomplished?

Step 1: Client initiates ACM study with Chematic Lab by providing details of their product, cleaning processes, and goals. Providing this information allows the application chemists to provide the most accurate hypothesis for your recommended cleaning plan. Our application chemists will then conduct a pre-call once they have completed their analysis of your data to make sure that their hypothesis fits into your capabilities and goals. Once the plan is agreed upon, the ACM study is initiated.

Step 2: Coupon-Beaker study is completed. This coupon-beaker study allows for the correct formulated detergent to be determined. Once the correct detergent is determined, the chemists work to optimize your cleaning process by playing with the pieces of your current cleaning process (Time-Action-Concentration/Chemistry-Temperature or TACT).

Step 3: Scaling-Up. Once the correct detergent and cleaning parameters are determined, the Chematic lab has the unique capability to scale up to mimic your cleaning process (CIP, COP, Laminar flow, manual scrubbing, etc) to further optimize the beaker studies and that our cleaning recommendation is the best for you. We also simulate failures and recommend what NOT to do (example hot rinse first vs. cold rinse).

How long does the ACM study take?

The turnaround time for these studies are dependent upon the scope of the project.

How many times is the customer updated along the process?

After the initial kick-off call to initiate the ACM study, the customer is updated on the status of the study on a weekly basis up until project completion, ending with a final results call.

Who completes the testing?

Chematic's Application Chemists complete the ACM testing. 

RESULTS

How will I obtain my results?

Data from testing is compiled into a report and the results, including photos, are shared via presentation during a scheduled follow-up call. On the call, the chemist will walk you through the cleaning recommendations, listen to your feedback, talks about next steps. 

After I receive my results, what are the next steps?

After your follow-up call, your next steps may include providing a sample, providing detergent information, or scheduling an onsite meeting or trial with a Dober representative.

What if through the ACM study a solution cannot be found to my problem?

The Chematic lab provides recommendations for your entire cleaning process (TACT-LINK TO TACT BLOG) not just the proper formulated detergent. If your cleaning process cannot be replicated, we can complete an onsite visit to obtain more insight into your cleaning process and offer suggestions for cleaning improvements.

About Chematic

What kinds of detergents does Chematic have available?

Chematic has acidic, alkaline, and neutral detergents available.  

In which industries can Chematic Formulated Detergents be used?

Chematic Formulated Detergents are customized cleaners for the pharmaceutical, biopharmaceutical, nutraceutical, and personal care industries.

Does Chematic's manufacturing meet cGMP standards?

Yes.

Can Chematic help me achieve validation?

Yes. Chematic offers an analytical technical transfer package to help with validation. Rather than be burdened with contracting out this analytical work, we provide our customers with everything you need to achieve validation with our formulated detergents.

Documents provided in this Analyticval Technical Transfer Package are:

- Toxicology Data (ADE Values)

- Chemical & Physical Data

- Validated HPLC & TOC Test Methods

- Transfer of Analytical Procedures

Chematic is also able to provide technical and validation support with approved NDA/CDA.

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