Pharmaceutical washing: advanced processes and Cleaning Validation according to the latest regulations
Pharmaceutical washing represents a critical phase within the production processes of the pharmaceutical, medical device and biotechnology industries. An effective washing system does not only aim to remove visible residues, but must ensure the repeatable and validated removal of chemical, microbiological and particulate contaminants, in full compliance with GMP regulations and the latest Cleaning Validation guidelines.
De Lama designs and manufactures high-performance industrial and pharmaceutical washing systems, capable of meeting the most stringent requirements in terms of efficacy, repeatability, traceability and regulatory compliance.
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The strategic role of washing in pharmaceutical processes
In the modern pharmaceutical context, washing is no longer a simple preliminary step before sterilization, but a critical and independent process that directly impacts:
final product quality
patient safety
regulatory compliance
reduction of cross-contamination risk
Components such as machine parts, tools, process accessories, containers, trays, carts, aseptic line components and transfer systems must be washed using repeatable, validatable and fully documented processes.
How the pharmaceutical washing process works
The pharmaceutical washing process is based on a controlled combination of mechanical, chemical and thermal action and time, optimized according to:
the type of contaminant
the material to be treated
the geometry of the components
A typical washing cycle includes:
Pre-washing Removal of gross residues and preparation of surfaces.
Detergent washing Chemical and mechanical action aimed at removing product residues, APIs, excipients, oils, greases and organic contaminants.
Intermediate rinses Complete removal of detergent residues.
Final rinse Performed with qualified water (PW, HPW or WFI), depending on the application.
Drying Controlled and repeatable, to prevent recontamination and ensure immediate availability of components for subsequent process steps.
De Lama washing systems ensure precise control of all critical process parameters, including pressure, flow rate, temperature, time and detergent concentration.
Washing and the new Cleaning Validation
Recent regulatory developments have further strengthened the role of Cleaning Validation, which today requires a scientific, risk-based and highly repeatable approach.
A pharmaceutical washing system must enable:
clear definition of critical process parameters
cycle repeatability under all operating conditions
complete data traceability
integration with site quality and validation systems
De Lama solutions are designed to facilitate Cleaning Validation, thanks to highly repeatable cycles, advanced software, rigorous control of critical parameters and documentation compliant with GMP requirements.
Advantages of De Lama washing systems
De Lama pharmaceutical washing systems offer numerous operational and regulatory advantages:
high contaminant removal efficiency
maximum process repeatability
reduced risk of cross-contamination
full support for Cleaning Validation
compatibility with delicate materials and complex geometries
integration with subsequent sterilization or decontamination processes
Each system is custom-designed, based on the specific requirements of the customer, the production process and the application.
Applications of pharmaceutical washing
De Lama washing systems are used in a wide range of applications:
pharmaceutical and biotechnology industries, including both solid oral dosage and sterile and aseptic production
medical devices
research and development laboratories
They can be used to treat process components, production accessories, line parts, containers, tools and carts.
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De Lama’s experience in industrial and pharmaceutical washing
For over 75 years, De Lama has been developing advanced technologies for washing, sterilization and decontamination for the most highly regulated industries. Field-proven experience, combined with continuous investment in research and development, allows De Lama to deliver reliable, validated solutions ready to meet the challenges of the new Cleaning Validation requirements.
This GLP washer for glasswares and parts washer belongs to DLWM series, which is the result of over 20 years of experience in industrial washing machines for the pharmaceutical sector.
Today all this know-how encompasses a whole range of concepts, improvements and totally innovative details for the sector.
The DWLM washer for glasswares and parts has been designed to meet GLP standars (Good Laboratories Practice).
The washer can be provided with modular basket for glasswares washing and open basket for generic parts washing.
Availabe with single or double door execution.
The DLWM series is designed for the treatment of all the accessories used in the pharmaceutical, health / hospital sector, in laboratories and research institutes, in the cosmetics and nutraceutical market.
De Lama washers are designed to fully comply with all the principles of ‘Cleaning Validation’
Made in both standard and custom models.
Capacity from 200 liters to 6,000 liters.
Here are some of the unique advantages and innovations found in the DLWM:
INNOVATIVE FEATURES:
100% GLASS DOOR. Door completely in glass, without any steel frame. The result is unparalleled cleanability for any other machine on the market.
MAGNETIC-CLOSING SYSTEM. Closure of the door in magnetic contact. Another element that guarantees safety, cleanability by minimizing the mechanical elements.
ANTI-BREAKING GLASS SYSTEM. thanks to the longitudinal inflation of the gaskets. Unlike the totality of the machines on the market, the gaskets inflate vertically, being allocated inside a groove dug inside the profile of the glass: the force that insists in a longitudinal direction prevents the breaking of the glass, as it is recurring for other market equipment.
AUTOCLAVE-CONCEPT CONSTRUCTION: 6 mm chamber thickness. Resistance, reliability, durability
ULTRA-CLEANABLE CHAMBER CONCEPT. No heating element inside the chamber: maximum cleanability.
AUTOMATIC CONNECTION FROM WATER LOOP TO INTERNAL TROLLEY: the internal trolley is equipped with an automatic connection to the water flow, in order to connect water circulation inside the trolley tubes, which is then sprayed directly by the nozzles positioned at hoc on the cart.
A TOTAL CUSTOMIZATION CONCEPT:
3D CUSTOMIZED TROLLEY. The trolleys are customized in shape, after having studied the 3d files of the items to be washed and after having carried out a 3D dedicated computer study of the washing cones on the trolley.
3D SCANNING IN CUSTOMER’S FACILITY, with no-stop production design process. With our portable scanners, De Lama technicians, in case of need. they can go to any part of the world to scan the parts to be washed in the customer’s premises in order to acquire the 3D file, then to work on the computer to obtain the best possible layout, both of the trolley, of the room, and of the washing cones .
OPTIONALLY REMOTED TECHNICAL AREA. The maximum customization and optimization of the spaces can be obtained as the technical cabin can be separated and can be allocated remotely, even above the roof of the car (even on the mezzanine floor) or even on the ground floor.
HOW CAN DE LAMA GET THE 3D FILES OF THE PIECES TO BE WASHED TO DRAW THE PERFECT TROLLEY AND CHAMBER LAYOUT?
De Lama is in possession of the most modern laser 3D manual scanners.
The files that are preparatory to the customized design of each washer can be acquired in 3 ways:
1- They can be sent by e-mail by the customer, if he is in possession of the same.
2- The customer can send to the De Lama facility copies of the parts to be washed so that they can be scanned with a 3D scanner in De Lama laboratories.
3- De Lama can send his specialized technical personnel to the Client Company to scan the pieces using a futuristic portable 3D scanner. In this way the customer can avoid any production stop or loss of time.
