Chad Rhodes | June 29th, 2020
For suppliers to differentiate themselves in the market, offering value-added services allows them to keep up with ever-changing needs and provide a personalized experience for their customers, and the critical cleaning agent industry is no different. Dober understands that implementing a new critical cleaning agent can be challenging and typically requires various internal and external resources to successfully implement a new cleaning chemistry. To assist with this change, we provide onsite support to our customers at multiple stages of the implementation process. From initial detergent screening through the validation process, the Chematic team are there every step of the way.
Our onsite support occurs in 3 stages, Initial Detergent Selection & Discovery, Cleaning Trials & Process Development and Implementation & Validation. This onsite support, in conjunction with Dober’s Custom Cleaning Evaluation (CCE) provides our customers with a complete value-added service offering. We want Chematic to be more than just a detergent.
Initial Detergent Selection & Discovery:
As we learned earlier during the CCE journey Steps 1 through 3, we focus on understanding the your cleaning process to appropriately select a Chematic detergent from our extensive portfolio of critical cleaning agents. However, there are situations where onsite discovery can assist in this process. The purpose of this onsite discovery is to review the current procedures and methods for cleaning and determine if there are opportunities to address site-specific cleaning goals. By conducting onsite discovery and working closely with the operators and validation groups during these initial stages, we can understand the issues and challenges of the current cleaning cycle and work to develop and implement alternate cleaning practices or chemistries to meet these cleaning goals.
Typical cleaning goals include:
Additional visibility to validation protocols, cleaning standard operation procedures (SOP's), and Health-Based Exposure Limits (HBEL's) for those assets targeted for cleaning process improvements are reviewed for cleaning process development. Representative worst-case products that are part of the current validation will need to be identified and tested during our Custom Cleaning Evaluation (CCE).
I recall conducting an onsite discovery a few years ago at a pharmaceutical manufacturer. During this discovery, we were able to uncover a significant cleaning issue associated with one of their granulation processes. The current validated procedure and cleaning agent resulted in extremely long cleaning times and a considerable amount of manual intervention. Many of the operators I interviewed expressed how challenging the process was and required a lengthy checklist to document the complicated cleaning procedure. My goal coming out of this onsite discovery was to make this cleaning process simpler and less time consumption. I wanted the operators to feel less frustrated, imagine working a full shift cleaning the same piece of equipment, only to have to come back the next day and continue.
Cleaning Trials & Process Development
This stage of onsite support is where our team can provide a personalized experience. Scaling up from the CCE cleaning studies into our customers pilot or production scale cleaning trials offers their own sets of challenges. Similar issues occur when scaling up from R&D formulation to production manufacturing. We’ve seen many situations where cleaning has been an afterthought. Having Dober onsite for this transition allows us to get to know your operation, inside and out. We work side by side with our customers to execute cleaning trials to assist in developing efficient and straightforward cleaning practices for each targeted manufacturing asset. Whether you're looking to improve your automated CIP cycle or develop a less labor-intensive manual cleaning process, we are here to help you achieve your desired cleaning goals.
For those goals specific to cleaning time reduction, understanding the actual cleaning times associated with each asset will be essential. Metrics can be calculated through batch records, cleaning checklists, automated CIP print outs, which are generated to calculate potential time and cost savings. Additionally, discussions with those individuals responsible for executing the cleaning process will help to provide details on actual cleaning times or issues associated with the validated cleaning process.
Implementation & Validation
Once the optimal detergent has been selected, the cleaning process developed, the final stage of onsite support now focuses on the implementation and validation of the new critical cleaning agent. Many of our customers turn to Dober for assistance with analytical methods, toxicology data information (ADE and PDE values), rinse water & swab analysis, and development of proper handling (PPE requirements) for our Chematic detergents.
During the onsite visit, we’ll evaluate the new cleaning method with the validation team as well as the operations group to ensure all cleaning goals have been achieved prior to the validation stage. We also provide a final project summary and presentation, which is delivered to the cross-functional team that was part of implementing the new critical cleaning agent.
By offering our customers onsite support, we can help reduce the challenges associated with implementing a new critical cleaning agent. These value-added services, along with the optimized cleaning processes, have been tailored specifically for our individual customer’s needs. We understand that each manufacturing asset and product has its unique issues specific to cleaning. Onsite discovery and support allow us to work side by side with our customers to meet your cleaning goals and maximize the use of your manufacturing assets. As for that granulation process with the extraordinarily long and labor-intensive cleaning procedure, our cleaning recommendations and Chematic detergent resulted in a cleaning process that is now less than one shift.