CIP/SIP Systems
CLEANING IN PLACE SYSTEMS
CIP/SIP STATIONS
BRAM-COR Cleaning in Place / Sterilizing in Place systems are designed to fully meet cGMPs requirements in cleaning and sterilizing practices commonly applied in pharmaceutical process lines.
BRAM-COR CIP/SIP systems are supplied as FIXED STATIONS or as MOBILE SKIDS, with manual, semiautomatic or automatic configuration.
CIP systems can be equipped with different utilities for heating, such as:
- Electrical heaters
- Heat exchanger by industrial steam
- Type and size of equipment to wash
- Required type of water and chemical agent
- Pharmaceutical product to remove
- Cleaning nozzles type
- Washing sequence, automation level
In CIP/SIP automatic stations, CIP critical parameters can be constantly monitored by the PLC and managed with cost-savings criteria. Some of these parameters are:
- Contact time of solution
- CIP supply temperature
- CIP return temperature
- Chemical conductivity (pH) for wash solutions
- Final rinse resistivity
- CIP solution flow rate
- Supply pressure
- Tanks levels
PRODUCT STERILIZATION SYSTEMS
BULK STERILIZATION
Sterilization by heat is one of the most widely used systems in pharmaceutical processes. BRAM-COR process tanks are equipped with a thermoregulation system, making it possible to heat the internal temperature of the tank, and therefore the content, up to the sterilization temperature (> 121°C), a state in which most of the microorganisms and enzymes are inactivated, guaranteeing the sterility of the final product.
BRAM-COR process technology foresees the achievement of the final goal through the following instrumentation/controls.
- Control of the internal tank temperature by means of a sensor
- Gentle agitation of the product in order to minimize heating time and ensure temperature homogeneity in the tank
- Heating system of the tank jacket through a half-pipe (single or double principle coil) and modulation apparatus and control of the industrial steam flow rate
- Predisposition for Filter Integrity Testing
PRODUCT STERILIZATION SYSTEMS
STERILIZATION THROUGH FILTRATION
For Thermolabile products, BRAM-COR offers methods of product sterilization through filtration, which does not destroy microorganisms but removes them through adsorption and trapping mechanisms that occur by passing the product through hydrophilic membrane cartridges.
BRAM-COR dual and single filtration skids offer several options and advantages:
- Custom filtration station sizing based on viscosity and product flow rate requirements
- Single filtration with 0.22 µm or 0.45 µm sterile filter
- Double filtration with sterile filter and pre-filter
- Filter cartridge materials conforming to its application (other materials available upon request)
- Valve system, differential pressure monitoring instruments to check cartridge fouling and sensors to minimize/remove air trapped in the filter housing
- Fully washable, sterilizable and drainable
The filtration skids come with a wide range of instruments available upon request:
- Conductivity meter: detection of the conductivity on the drain during the final rinse
- Air/gas presence sensor: to minimize the air inside the filter holder during the filling phase.
- Temperature probes: to detect the process and sterilization temperature at critical points.