Automated Washers – Changing the Paradigm of Pharmaceutical Cleaning

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 affect such crises within the future. they need to have an answer to tackle challenges like 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 big load off the healthcare workers, providing invaluable assistance in handling the COVID-19 situation. Pharma manufacturers, too, are following an equivalent 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 are often severe if the cleaning operation doesn't adhere to cGMP standards. the present COVID-19 crisis has further reinforced the importance of cleaning. Unlike sterilisation, during which the target and objective parameters are clearly defined, in cleaning, there's no absolute definition of cleanliness, and therefore the target varies from case to case. for instance , the cleaning target are often diluents, solvents, various chemicals, residues of previously processed products, lubricants, soil, and micro-organisms.

Manual cleaning isn't enough

In pharma manufacturing, the cleaning-in-place (CIP) mode is predominant and suitable for several equipment and assemblies like tanks, reactors, and granulation machines. Comparatively, the cleaning-out-of-place (COP) mode gets much less thought because it requires the utilization of GMP washing machines, often considered ancillary, non-directly productive equipment; hence, pharma manufacturers are usually less inclined to take a position in these machines and like manual cleaning.

Typically, manual cleaning is considered more flexible and cost-effective for complex-shaped and delicate parts and is usually used for cleaning small parts like tablet punches, nozzles, dosing pumps, and IPC bins. However, there are many risks presented by manual washing that overrule its benefits:

Incompetent – the most important hurdle in manual cleaning is that the inherent inefficiency, inconsistency, and difficulties in documenting and tracking the method . This raises an issue 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 must be adequately trained to get the specified results.

Insecure – As manual cleaning is solely hooked in to the operator’s skills, there's a big risk of cross-contamination. Additionally, the operator risks exposure to chemicals which may be harmful. Furthermore, the cleaning itself involves multiple hazards, like the utilization of predicament , 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 number of advantages in terms of meeting quality and safety regulations required by pharmaceutical regulations:

Increased reliability – Automatic washers are built to figure as per the procedures, which may be customised consistent with the cleaning requirement. The effectiveness of the operation are often checked by continuously monitoring the critical parameters. Human intervention is minimal and required only within the sort of selecting a cycle and starting/shutting down the machine.

Easy validation – Automatic washers facilitate cleaning validation, which may be a crucial activity for regulatory audits and is indispensable for establishing the general effectiveness of the method . By providing reproducible data, automatic washers ensure process uniformity and robust cycles, meeting the wants of successful cleaning validation.

High flexibility – Automatic washing are often as flexible as manual washing. It can process a good range of materials like steel, plastics, resins, and rubber within the same cycle. they will be wont to clean parts of diverse shapes and styles , from critical components in touch with the merchandise like 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 method is recorded by the automated washers, the documentation and traceability of the operation become simple.

Enhanced efficiency – Automatic washers increase the general 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 those factors cause reduced operating costs.

Safe and user-friendly – Current automatic washers on the market are designed ergonomically, considering both the wants of the cleaning operation and therefore the operators.

The cost advantages

For pharma companies, an washer are often a reliable long-term investment because it saves on several indirect costs related to the cleaning operation.

Reduced labor – Automatic washers eliminate the necessity for allocating dedicated personnel to manual cleaning, relieving them from this tedious and repetitive task.

Minimal training – there's no need for extensive training for the operators because the ergonomic automated machines are easy to work with minimal training.

Steady process– The time required for supervision is reduced significantly because the equipment follows a typical procedure.

Less use of resources – Decreased consumption of detergent, water, tools, clothing, and energy results in significant cost-saving within the future .

The following table shows the comparison of manual washing with automated washing and estimated savings possible per bin. Although per–unit costs may vary counting on site conditions, overall, automatic washers save to 52% of operational costs.

Before selecting an automatic pharmaceutical washer

The selection of the proper 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 internal control personnel, the acquisition and installation of a pharmaceutical washer become smooth and hassle-free. Consideration of the subsequent factors will resolve many issues:

A complete User Requirement Specification (URS) – A duly filled URS document from the pharmaceutical manufacturer can avoid half the issues faced during the installation of pharmaceutical washers. The URS should clearly state the intended use of the equipment, detailed design requirements suitable to the power , regulatory codes, and other specifications required by the drug company .

Load identification – it's best to spot the sort of load utilized in the pharmaceutical washer. Sharing this information with the supplier can help them select the foremost appropriate chamber size and style of the load racks.

Customisation – Washing equipment requires an area with proper architecture and dimensions matching that of the equipment. The machine should be customisable, and provisions must be determined just in case of additional services like water-for-injection or predicament .

The following checklist can further optimise the choice process:

What sort of residue is to be cleaned?
What sort of cleaning is required to get rid of the residue?
What is the specified temperature of the cleaning liquid?
What level of cleaning is required?
What are the size of the things which will be cleaned within the washing equipment?
How often do they have to be cleaned?
Is 21 CFR Part 11 compliance needed?
Is cleaning validation administered using pH or conductivity testing?
What sorts of documentation are required post washing?
Does the equipment got to be ready for online report collection?
Does the equipment require glove ports for manual intervention and cleaning?
What is the amount of various washes/rinses required in one cycle?
Is hot water/detergent mixing required within the equipment?

The bottom line

Cleaning is an important pharmaceutical operation with significant regulatory implications. Hence, pharmaceutical manufacturers should choose an answer which will suits all pharmaceutical requirements and still provide a favourable ROI. Although manual cleaning remains getting used partially by pharmaceutical companies, it's not a strong option, and therefore 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 within the long-term. the choice and installation of a pharmaceutical washer should be supported each stakeholder‘s requirements, its intended use, suitability to the plant facility, and most significantly , its compliance with the relevant market regulations.

References

https://pharma-trends.com/2021/03/18/automated-washers-changing-the-para...