The pharma industry uses on average about 30 percent of its available production time for the cleaning and disinfection of the lines, according to Diversey’s own proprietary data. 80 percent of all cleaning parameters are oversized, for reasons of safety and simplicity. Use of concentrations or chemical selection is in 50 percent of the cases not appropriate for the task. The sequence is often based on old and empiric data.
A necessary intervention
There are significant cost and resource efficiencies that are passing the industry by. The potential commercial value of the associated increase in productivity can be massive. However, identifying and resolving these inefficiencies is a significant barrier.
Pharma companies often lack the internal resources to engage in an optimisation study. Many will have functioning Cleaning-In-Place (CIP) systems. CIP is a unique method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and fittings, without or with a minimal disassembly. CIP and Sterilising-in-Place (SIP) systems are designed to both automate essential cleaning and disinfection processes and remove the need for time-consuming disassembly and assembly work.
There has been a fundamental shift in the pharma industry as ‘enterprise analytics’ and advanced data skillsets take hold and influence business decision making at all levels. These principles should be applied to cleaning and disinfection too. Deep dive analysis undeniably adds value throughout pharma operations, as long as the insights and evaluation are acted upon.
The entire industry is facing significant cost pressures too. As PWC notes in its 2017 Pharmaceuticals and Life Sciences Trends, every pharma company faces interest these days in what their product range is really worth. News stories of aggressive price increases and underlying economic pressures are raising the value issue and consumer awareness of this is rising. Efficiencies across the businesses must be found so if cost becomes a business critical factor, reductions can be found and afforded.
A methodical approach
Process optimisation depends on efficient, effective cleaning of difficult and stubborn soils, specific for the pharma industry. For decades, Diversey engineering has been a leader in driving significant operational efficiency gains through our integrated approach to cleaning automation.
Diversey Cleaning-in-Place (CIP) systems can be incorporated into all equipment used in the pharmaceutical industry. Automating the cleaning ensures repeatability, allows validation, minimises downtime and ensures a sustainable approach. Automating the cleaning cycle essentially converts batch pharmaceutical processes into a continuous operation of production and cleaning cycles.
The advantages of a well-designed CIP include reduced cleaning cycle times up to 25 percent, optimised use of detergent and water up to 25 percent, manual cleaning elimination and an overall significant reduction in total cost of ownership.
To assure a validated result for the pharma industry, Diversey offers a complete CIP solution package based on a 3-step approach:
- A unique CIP system, called the Diversey Flexible CIP
- A complete chemical portfolio, Diversey Clearklens
- An optimisation programme, Diversey CIPCheck
Diversey has developed and fine-tuned a unique CIP concept for the pharma industry, called Flexible CIP. This concept controls and manages the essential parameters required for CIP with the needs of individual operational settings for each individual object to be cleaned considered.
Every vessel, mixer, heat exchanger has its unique requirements for flow, concentration, temperature. Every recipe for each produced formulation has a different need, as soil and composition vary enormously.
Diversey Flexible CIP combines new insights to achieve lower material cost, lower installation costs and a friendly mechanical maintenance.
With the material recommendations, the technical centre is able to select from a complete chemical portfolio, Diversey Clearklens. Supply from the portfolio is guaranteed for five years, with no changes to formulas or specifications unless with at least six months’ notice and formulas are marketed throughout Europe promoting the harmonisation of international processes.
All Clearklens products are manufactured in facilities certified to ISO 9001 and ISO 14001 standards, and disinfectants supported under the European biocidal directive 98/8/CE.
Delivering a commercial advantage
Finally, pharma companies may have the perfect CIP approach, the most proficient use of chemicals and the clear direction of how to use the chemicals for each individual object, but if the entire process fails to be optimised, production could still be haemorrhaging value.
CIP optimisation with Diversey CIPCheck looks to assist manufacturers who seek to drive operational efficiency and cut costs should begin by performing a CIP Check of all their installations to identify areas for improvement. It will help determine whether incremental improvements such as balancing out the line capacity or adding a recovery tank to re-use water need to be made.
A high level of efficiency can be achieved by addressing CIP design, energy efficiency improvements, and process automation. A conscientious, methodical and technical approach to the cleaning and disinfection of lines will have a substantial positive impact on available production time, waste, energy costs, and environmental footprints. Improved product safety and increased production capacity will benefit both peace of mind and profitability, ultimately delivering a competitive edge in a turbulent marketplace.