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A Global Pharmaceutical Company Reduces Cleaning Time and Batch Rejection with Ecolab’s COSA PUR 81 Cleaning Agent
Situation
A global pharmaceutical company specialising in oral solid dose formulations was facing up to ten days of production downtime every time the stainless steel filters on its dryers failed. The filters would regularly blind due to the buildup of sustained release coating material and hence needed to be cleaned out of place. In severe cases these filters would fail mid-batch and the increased delta pressure would cause them to split which led to contamination of product and batch failures altogether.
Previously, a (COP) process was used where the filters had been soaked in alcohol for an extended period. However, this was not an efficacious nor ideal solution from a health safety environmental (HSE) perspective. Using this method resulted in having to regularly purchase new filters at a cost of 10k per filter with each dryer using three filters.
To reduce these costs, cleaning time and to improve HSE performance, a more effective solution was needed.
Solution
Ecolab’s team visited the site to assess the organisation’s current practices and determine where there was an opportunity for improved operational efficiencies.
Samples of what was currently being used including the clean filter, blinded filter, and the sustained release coating was sent to Ecolab for testing. These lab reports looked at different chemistries and parameters such as concentration, time and temperature as well as assessing the HSE impact a new solution would introduce.
Upon further lab tests and in depth discussion, Ecolab identified COSA PUR 81 as the specialised cleaning agent to be used for on-site trials. Prior to use in the manufacturing suite, the cleaning validation of the new procedure was completed with support using the Ecolab online cleaning validation website. The organisation then conducted their plant-scale trial. This trial was very successful, replicating results observed at laboratory scale, and resulted in the company securing an increased supply of the product for further optimisation and commercialisation.
Results
In addition to reducing their production downtime, the company was able to decrease the amount of commercial product lost as well as the amount of time that was spent cleaning. Previous cleaning efforts alone took approximately 10 hours. With this new process it is estimated that the optimised cleaning time can be reduced by up to 80%.*
The impressive results can be seen on the right.
*Client supplied and validated data directly to Ecolab
How Ecolab Adds Value:
Site Surveys
Ecolab offers site-surveys from a trained technical team to review new or existing manufacturing and cleaning process.
VALUE+
- Technical recommendations are matched to your most relevant objectives and key performance indicators (safety, water savings, efficiency, etc.)
- Formal report summarises potential savings
- Delivers implementation strategy that minimises production disruptions
Lab Studies
Ecolab offers a laboratory team that can analyse soils, identify residues and test samples.
VALUE+
- Creates a quicker and more successful cleaning recommendation
- Ensures the chemistry solution is effective against your unique, targeted soils
- Helps determine optimal dilution and implementation parameters
Disinfection with Chemistry vs. Water
Ecolab can help implement a validated strategy to clean CIP systems with registered chemical disinfectants as an alternative to water and heat.
VALUE+
- Saves water which can help meet sustainability goals
- Reduce energy and time needs by removing need to heat water to required temperature
Validation Assistance
Ecolab can assist with the complex validation process and change controls by providing guidance and documentation.
VALUE+
- Guidance includes:
- Cleaning process design and development
- Cleaning process validation
- Continuous cleaning process verification - Helps ensure process stays in line with regulatory expectations and acceptance criteria
Dedicated Regulatory Team
Ecolab leverages industry expertise to deliver insights and guidance on regulatory expectations, trends and available tools to help ensure compliance for product safety and quality.
VALUE+
- Helps ensure compliance with cGMP to ensure cleaning and disinfection meet product safety and quality requirements
- Help implement validations that meet regulatory expectations
Customer Training
Ecolab’s team is comprised of experts to help you implement, manage, and maintain quality and compliance requirements and protocols.
VALUE+
- Gain valuable best-practices and implementation strategies from trained field and technical experts
- Reduce troubleshooting time from on-site support and process training to resolve problems quickly