Pure Steam (PS), often directly called Clean Steam (CS), is the right way to solve the problem of sterilization of the equipment, not only in wfi manufacturing, but virtually in every critical point of any process line (biopharma, food, beverage, cosmetics and so on).
Pharmaceutical Pure Steam Generator Mod. CPSG produces dry, saturated steam, suitable for sterilization of pharmaceutical production plants, for direct contact with Active Pharmaceutical Ingredients, for Parenteral and Non-Parenteral dosage form applications. The steam, when condensed, meets USP requirements for Water for Injection (WFI). The steam is purified using centrifugal and gravity separation methods.
cGMP and PED standards are baseline criteria in Bram-Cor CPSG design and construction: material and instruments are certificated and all welds are made by qualified welders. In detail:
The system shall be fed with Purified Water and heated basically through Plant Steam but also by Electricity or even Superheated Water. Capacities range: from 20 to 5000 kg/h.
See also pure-steam-generators.com
|PURE STEAM – quality critical attributes|
|PHISICAL / CHEMICAL||Ph. Eur.||USP|
|Conductivity||Not defined||≤ 1.3 μS/cm @25°C|
|TOC||Not defined||≤ 0.50 mg/L|
|Bacterial count||≤ 10 CFU/100 ml||≤ 10 CFU/100 ml|
|Bacterial endotoxins||< 0.25 IU/ml||< 0.25 EU/ml|
Thanks to the advent of CIP (Clean-In-Place) and SIP (Sterilization-In-Place) technologies, sealed systems such as pipes, vessels or process equipment in technical process plants can be cleanded without the need to disassemble the systems. This is a great time-saving advantage in industrial sectors where fixed and regular cleaning was required, such as pharmaceutical industry, food and beverage.
CIP – CLEANING IN PLACE
The cleaning method enables the internal surfaces of a sealed system to be entirely cleaned without disassembly or only by disassembling a limited number of components. The CIP process is completely automatic, to respect defined process times and parameters.
The cleaning operation -with temperatures up to 100°- is performed through a series of steps with turbulent flows: Pre-rinsing, Cleaning with lye (tipically NaOH), Rinsing off the lye with water, Cleaning with acide, Rinsing off the acide with water, Thermal or chemical sterilization, Final water rinsing
SIP – STERILIZATION IN PLACE
Steam sterilization of the pharmaceutical processing plant takes place after CIP, as a further sterilzation step. It is an indispensable operation in areas where germ reduction plays a prime role. SIP ensures, in fact, that any microorganism still active in the plant is erased. The system can use hot water or saturated pure steam at high temperatures (> 120 °C) and about 2 bar, for a variable period (>60 minutes) depending on the specific application.
BRAM-COR Clean in Place systems are designed to fully meet cGMPs requirements in cleaning and sterilizing practices commonly applied in pharmaceutical process lines and plants. With an extensive range of systems, BRAM-COR meets the most diversified needs, with mobile and fixed stations, with dedicated solutions that were also the challenges posed by sterilization with superheated steam, thanks to a specific and calibrated design.
Each BRAM-COR CIP/SIP equipment is designed (in single or multitank configuration) to achieve the most effective and easily validable cleaning systems, starting from: 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.