The cleaning devices are for cleaning in batches. The cleaning steps with liquid medium are circulated and the cleaning device is fully drained after each phase. We provide you with a cleaning package which meets all customer requirements, following cGMP and EHEDG regulations. Its thorough qualification leads in a validated cleaning process. Various cleaning recipes for different equipment and residues are easy to create and to store over operator interface. No programming knowledge and tooling is required. Access is prevented due to different protection levels. All events are recognized in the audit trail.
Versatile device characteristics
- Cleaning with different water qualities and detergents
- Cleaning with different solvents
- Batch cleaning with recirculation in cabinet cleaning device
- Cleaning in place
- “Once through” cleaning, adding detergents in direct flow
- Fully automated solutions for in-feed, opening and closing of the IBC, out-feed
- Cleaning in ex-environment (ATEX)
- Validated cleaning solutions
cGMP compliant design
- Chamber variants in different sizes
- Hardened double safety glass doors with gastight inflatable seals
- Automated door opening vertical (PDC) or horizontal (PCC)
- Checked rotating on wash
- Sterile clamp connections DIN 11864 - T3
- Chamber steel sheet material quality AISI 316L (EN 1.4404 / 1.4435)
- Chamber steel sheet surface quality mirror polished (EN 10088 2P)
- T-membrane valves (none dead leg design)
- Membrane and O-rings in PTFE / EPDM
- Only one inlet medium connection over manifold membrane valve block
- Plug connections (no screws) and easy removable parts inside the cleaning chamber
- Surface quality to customer’s request but at least Ra < 0.8 μm
- Bottom and top surface in the cleaning chamber are sloped so that a full drainage is guaranteed
- Camber radius minimum 1” Ø
- Piping with slope > 2 % for full drainage
- Tubes orbital welded and polished
- Total dead leg free design of cleaning chamber and piping system
- Circulating pump self draining and in AISI 316L
- Inline heating system in circulation piping; steam or electrically heated
- Customized wash racks with internal nozzle system; every item to be washed has its specified position
- Automated connection between circulated piping and wash rack
Documentation for qualification and validation
Different levels of documentation according to customer recommendations are available. The compilation of different drawings, lists, certificates and specifications make the qualification possible. In order to validate the system FAT/SAT-protocols and a special IQ/OQ-package are available.
Professional cleaning in explosion proofed areas
Complete cleaning device compliant to ATEX regulations (including safety intergraded level, SIL) for cleaning with solvent or located in a possible dust polluted atmosphere.
Multi-chamber solution
To increase cleaning through put, a cleaning system with a chamber for liquid phases and a chamber for drying are built together. Transportation is done with an automated in-feed, pass through and out-feed system.
Regulations:
- FDA
- 21 CFR part 110: Food
- 21 CFR part 210& 211: Pharmaceuticals
- 21 CFR part 177: Non stainless steel parts
- 21 CFR part 11: Electronic records
- EHEDG
- Stainless steel in contact with process medium
- Material ANSI 316L, 1.4401, 1.4404, 1.4435
- Material Certificates: 2.2 or 3.1
VCD cleaning device for containers and drums
Automated inside cleaning device for containers, reactors, mixing systems, fomenters and other hollow parts with inlet and outlet for cleaning medium. Automated solutions for cleaning containers with automated opening and closing of the container inlet and outlet. Various options as medium circulating module, drying module, steam out and dosing modules are available.
PDC cleaning device for parts and drums
Fully integrated cleaning device for inside and outside pre-steam, pre-wash, wash, neutralize, rinsing and drying of equipment in contact with the produced product as containers, drums, bottles, funnels, pipes, hoses, sieves, punches, dies, pumps, valves … and also machinery tools and tooling used in the field of pharmaceutical, cosmetic and high grade food industries. Special racks are designed for the various parts to be cleaned, according to customer requirements.
PCC cleaning device for containers and large parts
Fully integrated cleaning device for inside and outside pre-steam, pre-wash, wash, neutralize, rinsing, steam out and drying of equipment such as containers, drums, pallets and large equipment parts used in the field of pharmaceutics, cosmetics and high grade food industries. Fully automated solutions for in-feed, out-feed and opening / closing of full containment IBC’s available. Special racks are designed for the various parts to be cleaned, according to customer needs.
Flexible cleaning
Device configuration
Due to their use of standard modules, the cleaning devices can be very flexibly configured. There can be various water qualities and detergents attached to the cleaning device. In the design of the cleaning chambers, beside the standard cleaning chamber sizes, in addition cleaning solutions of are very flexible for the user requirement for special sized cleaning chambers. Beside standardized cleaning processes, customer recommendations are easily integrated. The materials and components are used in accordance with customers’ specifications.
Easy use and handling
Control elements of Siemens or Allen Bradley are used, also touch screens of 10” to 15” size. The well known components of the suppliers guarantee best industrial quality and availability. The operator interface is based on well accepted modules of these suppliers. The software used in compliance with the FDA regulations 21 CFR part 11 and GAMP 5. The self explaining and structured operator interface guides the operator safely and securely in any situation. All required cleaning process parameters are shown on the screen. Operator database with password managing system for different access levels.
Volume measurement of dosing
The volume measurement of detergent per stroke is precise and able to validate.
Conductivity measuring
The adjustable conductivity controls can be set when the step rinsing is finished and the next phase of drying can start. The rinsing step is repeatable according to the settable value in the cleaning recipe.
PH value measuring
In order to control the cleaning medium concentration and / or the concentration before drainage of the cleaning medium, the in-line PH value measuring allows automated adding of detergent.
Drying air system
The heat battery heats the flow of air, which is positioned after the high performance fan. Heating can be electrical or by steam.
Monitoring of air filter
There is a pre- and a main filter. Different filter qualities can be chosen from F9 to H14. Differential pressure sensor on main filter checks online the functionality and shows this information on the touch panel. Test port on main filter box (e.g. DEHS tests).
Doors
One door or pass through cleaning systems with transfer chamber functionality. Using two door systems, the doors are interlocked. Out-feed door (clean side) opens only when cleaning process has been successful. In the same time the in-feed door (dirty side) stays closed.
Pure steam application
Pre-steaming for melting down residues on to be cleaned parts or sanitization of cleaned parts after rinsing.
Rotating wash item racks
Special cleaning processes require the ability to rotate the items to be cleaned during the cleaning process. The required drive for the rack is placed outside of the cleaning chamber.
Automated handling and opening
For multi chamber and high containment applications, an automated transport system is recommended. The automated transport system in pharmaceutical grade design has no drives installed in the aqueous cleaning chamber. The system consists of a moving frame driven from the in-feed side and out-feed side. The wash items are placed in the in-feed storage position. Loading the wash items from the in-feed storage position into the cleaning chamber is fully automated. After the cleaning process, the wash item is automatically transferred into the next chamber or to the out-feed storage position, regarding the machine configuration. Cleaning of containers encloses also fully automated opening and closing of valves, split valves and lids, according to customer specifications. The automated identification of the wash item can be done with a bar code or RFI reader system. The cleaning recipe is chosen automatically from the recipe database regarding the transferred information.