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The Importance of the Washing Process in the Pharmaceutical Industry
[/vc_column_text][vc_separator color=”sandy_brown” border_width=”3″ el_width=”10″][/vc_column][/vc_row][vc_row css=”.vc_custom_1564073259210{margin-top: 25px !important;margin-bottom: 25px !important;}”][vc_column width=”3/4″][vc_column_text css=”.vc_custom_1597760247088{padding-bottom: 20px !important;}”]Cleaning procedures become increasingly important in pharmaceutical manufacturing environments and they have been recognized as critical steps in improving the quality of the final product. A fundamental part of an effective cleaning process is the use of equipment that meets regulatory compliance, validating systems and processes, and ensuring quality in all phases of engineering, exceeding the most complex safety standards. Aware of the importance of validated cleaning processes, the solutions of the manufacturer IWT, a partner of STEQ, have an extensive line of washing equipment with state-of-the-art technology, including the M-Line, a compact and versatile high-pressure washer.
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M-Line: Mobile High Pressure Washer
- Ideal flushing system for contact units used for conveying and storing materials and fluids, drums, preparation tanks, bins, blenders and miscellaneous containers;
- Suitable for a wide range of CIP and COP applications;
- Constructed of AISI 316L Stainless Steel, GMP and FDA compliant;
- Compact design that provides better ergonomics and weight reduction;
- Up to 70 Bar of pressure for optimum mechanical action of water and fast cycles;
- Water flow of only 40 l/min for reduced water and chemical consumption;
- Quick-locking connections for hydrokinetic booms.
Compliance
IWT cleaning systems are developed following worldwide standards and guidelines:
- ISO9001
- EU GMP (Annex 11 and 15)
- FDA 21CFR part 11 for software and part 210-211 (GMP)
- ASME – BPE
- GAMP5
- ISPE
- Eur and USP
Qualification
The ultimate goal of any qualification is to ensure that the equipment is not only suitable for its intended purposes, but that it is also built to the user’s requirements specifications, meeting industry guidelines and standards. IWT shares the protocols and documents upfront in order to set clear and detailed design goals, which are critical to the design and manufacturing phases of the equipment.
Engineering
The design of washing equipment and its accessories has a huge impact on the time, efficiency and yield of cleaning processes. Proper engineering also influences how easily material can be moved off production lines and washing areas. To minimize downtime between production batches, IWT applies a risk-based approach to needs, layouts , and work procedures with the goal of delivering quality equipment combining performance, time, and cost.
Safety
All IWT systems are designed with total safety in mind, both for the operator and the process. Calibrated probes, sensors, and specific controls are incorporated to ensure real-time monitoring of parameters and accurate process diagnostics. A safe process ensures not only a clean load, but also prevents any possible cross-contamination between product batches and microbial growth during downphases.
M-Line Mobile High Pressure Washer:
A proven solution to reduce utility and labor consumption
When a high-pressure automatic cleaning system is used, a significant reduction can be achieved in terms of water consumption, detergent and manpower needs. The great time savings can be identified in the wash cycle itself, but also in the mandatory process quality checks.
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Comparison: Manual Washing vs M-Line Washer
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Performance: Hand Wash vs. M-Line Washer
Material: Stainless steel bin with dust residue (1,500 liters)*[/vc_column_text][vc_single_image image=”5132″ img_size=”large” alignment=”center”][vc_column_text]
Material: Stainless steel blender with powder residue (6,000 liters)*[/vc_column_text][vc_single_image image=”5141″ img_size=”large” alignment=”center”][vc_column_text css=”.vc_custom_1597669804077{padding-bottom: 20px !important;}”]
High-Pressure Mobility
Built in compliance with key regulatory guidelines, the M-Line can be easily moved and connected to multiple washing stations. The machine can be coupled with a wide range of cleaning heads and hydrokinetic lances to achieve 360° coverage of all surfaces within a 1.5 m (60 in) radius. The containers can be installed with the wash heads through dedicated and customized accessories.
Additional M-Line Resources
- Shockproof protection mounted on wheels
- Quick-locking connections for hydrokinetic booms
- Entrances for different water qualities
- Detergent dosing stations
- Integrated electrical cabinet
- Final rinse water conductivity control
For more information about the M-Line Mobile High Pressure Washer, please contact us at contato@steq.com.br.
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