The ultimate priorities for the pharmaceutical industry are the safety, quality and efficacy of its end products, and the hygiene of manufacturing facilities is a fundamental foundation to consistently delivering on these concerns. Preventing and controlling contamination for both surfaces and equipment in pharmaceutical facilities is complex and can represent a significant drain on resources.
Soil removal – a painstaking process
The soils identified for removal tend to be a mix of hard to remove, potentially unidentifiable chemicals, making immediate cleaning and the selection of the correct detergent difficult. In addition, often the soils are on pharmaceutical equipment that are small, intricate and expensive, so care and attention has to be paid to ensure a full and thorough clean, and to prevent damage.
The most suitable and effective procedure for removal can be unclear, and can result in wasted time and a lack of productivity from the pharmaceutical facility. Pharmaceutical operations tend to have a standard operating procedure for cleaning, but some of the processes, particularly soil removal can be laboured and damaging to productivity.
Detergent selection – a drain on resource
Clarifying the exact detergent to use in each circumstance can take an inordinate amount of time. Trial and error to select the appropriate cleaning chemical can also result in a large amount of wasted batches of an individual product, and costly inefficiencies for the entire facility operations.
A laboratory evaluation can select the correct cleaning detergents and parameters, based on a small sample sent from the facility. This is then confirmed with a field evaluation. The laboratory should be informed of the substrate and any in-facility constraints. Residue limits and the contribution of various parameters to performance should also be considered.
Cleaning or removing soils from equipment may require a single detergent, or a multi-component formulation. The application of the selected detergent is crucial, be that wetting, dispersion, solubilisation, emulsification, and oxidation. Ensuring the first procedure for removal succeeds is hugely valuable when one lost batch of products can cost many thousands of pounds.
The growing need for clarity
Traditionally, once a cleaning procedure is performed successfully and validated, this is considered a standard process. The approval documentation is signed off and stored, never to be revisited. Revalidation and the need to re-evaluate detergents and processes is proactively avoided in some cases.
This provides contaminants an opportunity to develop from new substances and mixes of chemicals introduced for new batch development. There is a need for cyclical clarity on cleaning procedures and the chemicals to be used.
Shifting governance and regulatory attention, such as REACH and BPR, has added to the challenges of preventing and controlling contamination. Cleaning validation has key prerequisites, namely selecting suitable cleaning agents and determining justifiable cleaning process parameters. Validation by global headquarters for regional sites is also required by some pharmaceutical businesses. Proper selection of these cleaning agents and parameters could simplify cleaning validation efforts significantly.
Optimising the process, retaining control
For over 20 years, Diversey have been developing innovative hygiene solutions for sterile and non-sterile production. ClearKlens® DSP (detergent selection programme) provides an efficient protocol and chemical selection to clean a specific soil, accelerating pharmaceutical standard operating procedures.
The process is executed in three phases. Firstly, a sample of soil is sent to the DSP technical centre. Secondly, a team of experts will test different cleaning chemistry and procedures, developing a report that details the best method for removal of the soil. Thirdly, the report can be used by the facility to develop a further cleaning protocol based on the parameters defined, including chemical type, concentration, cleaning time, temperature, cleaning method and water quality.
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. The experts will also apply the unique Clearklens Diversey Cleaning-in-place (CIP) method of cleaning for interior surfaces of pipes, vessels, process equipment, filters and fittings, without or with a minimal disassembly.
Recently, a leading player in drugs and medicines required assistance from Diversey in the launch of seven generic drugs. The launch would have been impossible without a fully validated cleaning process. To ease the time and costs associated with validation, it was crucial for the business to find a detergent that would successfully remove 100 percent of production residues. Diversey’s lab trialed several formulas, and identified Clearklens NTC as the required solution. The detergent selection programme saved the company months of trials, and significant time and effort finding the one suitable detergent – this would have also potentially caused a delayed launch.
The argument for automation
Process optimisation depends on efficient, effective cleaning of difficult and stubborn soils, specific for the pharma and cosmetic industry. Diversey Cleaning-in-Place (CIP) systems can be incorporated into all the equipment for the pharmaceutical industry. Automating the cleaning and applying the unique Diversey vision and know-how ensures repeatability, allows validation, minimises downtime and ensures a sustainable approach.
Automating the cleaning cycle essentially converts batch pharmaceutical and cosmetic processes into a continuous operation of production and cleaning cycles. Soil removal is a fundamental element of these continuous operations, and should be considered as a process which can be built into the cleaning cycle and similarly optimised. Defining and implementing the most effective detergent selection and application programme for pharmaceutical facilities is a multifaceted and difficult operation, but one that can pay significant dividends if it is considered and addressed robustly.