While industries worldwide are grappled with the COVID-19 pandemic, the pharma industry is on the frontline of the battle facing new challenges. These tough times have clearly shown that the pharma companies must take a relook at their resources and infrastructure to deal with such crises in the future. They must have a solution to tackle challenges such as limited human resources, remote handling of systems, and uninterrupted production with maximum output. To confront these issues, automation is coming to the rescue.
Automated systems are already taking a significant load off the healthcare workers, providing invaluable assistance in dealing with the COVID-19 situation. Pharma manufacturers, too, are following the same footsteps, adopting either fully automated processes or upgrading the routine operations where minimal human intervention is required.
Cleaning is one operation of critical importance for pharmaceutical, biopharmaceutical, and research facilities because the implications can be severe if the cleaning operation does not adhere to cGMP standards. The current COVID-19 crisis has further reinforced the importance of cleaning. Unlike sterilisation, in which the target and objective parameters are clearly defined, in cleaning, there is no absolute definition of cleanliness, and the target varies from case to case. For example, the cleaning target can be diluents, solvents, various chemicals, residues of previously processed products, lubricants, soil, and micro-organisms.
Manual cleaning is not enough
In pharma manufacturing, the cleaning-in-place (CIP) mode is predominant and suitable for many equipment and assemblies such as tanks, reactors, and granulation machines. Comparatively, the cleaning-out-of-place (COP) mode gets much less thought because it requires the use of GMP washing machines, often considered ancillary, non-directly productive equipment; hence, pharma manufacturers are usually less inclined to invest in these machines and prefer manual cleaning.
Typically, manual cleaning is regarded as more flexible and cost-effective for complex-shaped and delicate parts and is commonly used for cleaning small parts such as tablet punches, nozzles, dosing pumps, and IPC bins. However, there are many risks presented by manual washing that overrule its benefits:
Incompetent – The biggest hurdle in manual cleaning is the inherent inefficiency, inconsistency, and difficulties in documenting and tracking the process. This raises a question about the validity of the procedure to the regulatory bodies.
Operator-driven – In manual cleaning, success depends on how rigorously the operators follow the validated protocol and their skill. Additionally, the operator needs to be adequately trained to obtain the desired results.
Insecure – As manual cleaning is solely dependent on the operator’s skills, there is a significant risk of cross-contamination. Additionally, the operator risks exposure to chemicals that might be harmful. Furthermore, the cleaning itself involves multiple hazards, such as the use of hot water, detergents, and steam.
How do automatic washers help
Automated washing equipment uses a standardised procedure for cleaning, which produces reproducible, consistent results. They also offer a host of benefits in terms of meeting quality and safety regulations required by pharmaceutical regulations:
Increased reliability – Automatic washers are built to work as per the procedures, which can be customised according to the cleaning requirement. The effectiveness of the operation can be checked by continuously monitoring the critical parameters. Human intervention is minimal and required only in the form of selecting a cycle and starting/shutting down the machine.
Easy validation – Automatic washers facilitate cleaning validation, which is a crucial activity for regulatory audits and is indispensable for establishing the overall effectiveness of the process. By providing reproducible data, automatic washers ensure process uniformity and robust cycles, meeting the requirements of successful cleaning validation.
High flexibility – Automatic washing can be as flexible as manual washing. It can process a wide range of materials such as steel, plastics, resins, and rubber in the same cycle. They can be used to clean parts of diverse shapes and designs, from critical components in contact with the product such as format parts, punches, dies, mixing containers, IBCs, and drums to large production parts including hoses, housings, and valves.
Clean records – As every step of the process is recorded by the automatic washers, the documentation and traceability of the operation become simple.
Enhanced efficiency – Automatic washers increase the overall efficiency of the cleaning operation by optimising multiple factors, including water and detergent quantity, total process time, material flow, drying time, and energy consumption. All of these factors lead to reduced operating costs.
Safe and user-friendly – Current automatic washers on the market are designed ergonomically, considering both the requirements of the cleaning operation and the operators.
The cost advantages
For pharma companies, an automatic washer can be a reliable long-term investment as it saves on several indirect costs associated with the cleaning operation.
Reduced labor – Automatic washers eliminate the need for allocating dedicated personnel to manual cleaning, relieving them from this tedious and repetitive task.
Minimal training – There is no need for extensive training for the operators as the ergonomic automated machines are easy to operate with minimal training.
Steady process– The time required for supervision is reduced significantly as the equipment follows a standard procedure.
Less use of resources – Decreased consumption of detergent, water, tools, clothing, and energy leads to significant cost-saving in the long term.
The following table shows the comparison of manual washing with automated washing and estimated savings possible per bin. Although per–unit costs may vary depending on site conditions, overall, automatic washers save up to 52% of operational costs.
Before selecting an automatic pharmaceutical washer
The selection of the right pharmaceutical washer to suit all pharmaceutical requirements needs the consideration of several factors. With proper budget allocation and planning with all stakeholders, including production, engineering, maintenance, and quality control personnel, the purchase and installation of a pharmaceutical washer become smooth and hassle-free. Consideration of the following factors will resolve many issues:
A complete User Requirement Specification (URS) – A duly filled URS document from the pharmaceutical manufacturer can avoid half of the problems faced during the installation of pharmaceutical washers. The URS should clearly state the intended use of the equipment, detailed design requirements suitable to the facility, regulatory codes, and other specifications required by the pharmaceutical company.
Load identification – It is best to identify the type of load used in the pharmaceutical washer. Sharing this information with the supplier can help them select the most appropriate chamber size and design of the load racks.
Customisation – Washing equipment requires a room with proper architecture and dimensions matching that of the equipment. The machine should be customisable, and provisions must be determined in case of additional services such as water-for-injection or hot water.
The following checklist can further optimise the selection process:
- What type of residue is to be cleaned?
- What type of cleaning is required to remove the residue?
- What is the required temperature of the cleaning liquid?
- What level of cleaning is required?
- What are the dimensions of the items that will be cleaned in the washing equipment?
- How often do they need to be cleaned?
- Is 21 CFR Part 11 compliance needed?
- Is cleaning validation carried out using pH or conductivity testing?
- What types of documentation are required post washing?
- Does the equipment need to be ready for online report collection?
- Does the equipment require glove ports for manual intervention and cleaning?
- What is the number of different washes/rinses required in one cycle?
- Is hot water/detergent mixing required in the equipment?
The bottom line
Cleaning is an essential pharmaceutical operation with significant regulatory implications. Hence, pharmaceutical manufacturers should opt for a solution that will comply with all pharmaceutical requirements and still provide a favourable ROI. Although manual cleaning is still being used in part by pharmaceutical companies, it is not a robust option, and the results are largely dependent upon the operator. Automated washing machines overcome the challenges presented by the manual cleaning process and are highly cost-effective, providing several benefits in the long-term. The selection and installation of a pharmaceutical washer should be based on each stakeholder‘s requirements, its intended use, suitability to the plant facility, and most importantly, its compliance with the relevant market regulations.