DE10114927A1 - Preparation of liquid and gaseous distillates, used in cleaning, disinfecting, sterilization and distillation units, employs matrix steam generator - Google Patents

Abstract

Distillation takes place in a steam generator comprising a monolithic or packed, gas-permeable matrix. This preferably comprises porous metals and/or ceramics. Preferred Features: The matrix fills the distillation chamber only partially and/or is only partially subjected to its temperature and pressure conditions. Sterile filtration precedes or follows the distillation chamber. Excess and/or reduced pressure is applied. Additives raise or lower the boiling point of the aqueous solutions. Distillation takes place in increased or reduced pressures, in single or multistage processes. Hollow objects are steam-tested individually or collectively, under increased or reduced pressures produced in the process. They are connected to the cleaning facilities of the process, and tested with test contaminants. To remove salts after steam generation, the pressure is increased and in counterflow, desalination is effected with and without chemical additives. The matrix region in which both distillation and concentration of salts occurs, is replaceable and/or separately regenerable. To remove salts, a distillation stage precedes the process.

Description

Various studies have shown, particularly in the presence of mucous and / or protein-containing soiling, serious problems with the hygienic preparation of various goods such as food, surgical instruments, implants, pharmaceuticals and a large number of objects in the medical field, which are microbially contaminated and poor due to the thermolability are to be cleaned, disinfected or sterilized. In particular, from a hygienic point of view, serious problems with contamination with prions, viroids, viruses, chlamydia, rickettsia mycoplasma bacteria that are smaller than 1 µm can be seen, because contrary to all expectations, the hygiene technology used to date in sterile goods processing contains considerable gaps in validation. It had to be found that a significant proportion of nosocomial infections, e.g. B. from staphylococci, enterococci, glue points to validation gaps in the hygiene chain and the intended use of this technique. Outside the use of single-use instruments (destruction, e.g. of invasive surgical instruments), there are currently no prions that cause TSE (transmissible spongiform encephalopathies) with regard to the extensive risk of infection. For prion inactivation it is known that even hot air sterilizations of 30 minutes at 180 ° C are insufficient and even at high prion concentrations or in caramelized, coagulated inclusions the vacuum steam sterilization of 60 minutes at 134 ° C cannot ensure complete prion inactivation. Likewise, sterile filtration (0.2 µm) of prions in solution does not lead to success due to the small particle size below 5 nm. However, it is advantageous to use an absolute filter over 0.45 µ or depth filter (according to DE 196 40 034.1) cyclones and centrifugal separators for the process described below in the context of the prefiltration in order to separate plaques and tissue fragments containing prions before they can go into solution. In particular, the measures for instrument reprocessing to date after invasive interventions in suspected CJD cases (guidelines for instrument reprocessing in suspected CJD cases. Bundesgesundheitsblatt 7/98; pp. 279-285) show serious deficiencies in handling undetected TSE infection carriers during the incubation period ( 5 years to several decades) as well as the use of conventional cleaning and disinfection machines (RD machines) which, contrary to the guidelines, do not allow a validated cleaning performance and therefore residual contaminations containing prion remain or are distributed in the system or the instruments. Furthermore, prions have the property of a high affinity for metal / stainless steel surfaces. At the moment, the conventional RD vending machines used in hospitals are not pressure-resistant, so that no comparable prion reduction is possible between the individual cycles, as is the case, for. B. in animal meal production over decades with a reduction rate of approx. 10 ^-12 by steam sterilization of 2 bar (overpressure = 3 bar) at 134 ° C for at least 20 minutes.

A great helplessness is also in dealing with thermolabile Furnishings, mattresses, dishes, laundry, toilets, care items and the handling of waste water and cleaning solutions in the event of contamination with highly infectious pathogens such as Ebola and Marburg viruses.

A major deficiency in feed water contamination has been identified  the methods DE 196 40 034.1 and DE 197 55 861 are eliminated. Furthermore, with the Process DE 100 06 767.0 for cleaning, disinfection and sterilization control important problem areas are recognized that have so far been insufficiently ascertained analytically were. Basically, these are flushing shadows in narrow lumens and the inadequate penetration of mucous and / or proteinaceous soils which in Standard programs e.g. B. steam or low temperature sterilization lead to incomplete inactivation of pathogen and therefore associated with there are nosocomial infection risks. Safe, validatable removal / decontamination prionic soiling on instruments or in cleaning solutions cannot be achieved by these methods.

State of the art

Various methods of cleaning and / or disinfection with aqueous are known and gaseous cleaning agents and disinfectants as well as sterilization with hot air, Superheated steam, plasma, formaldehyde, ethylene oxide, radioactive radiation, etc.

Indispensable prerequisite for the success of the final sterilization process is the pyrogen-free pre-cleaning. Essentially, be with the following Methods for cleaning and disinfection u. a. Realized conditions, their importance are already known for steam sterilization, without this being necessary and importance for the pre-cleaning have been realized. With this in mind so far from none of the manufacturers for cleaning and Disinfection machines on the currently existing extensive patient risks pointed out and a comparable, proposed with the method DE 196 40 034.1, feed water-validated cleaning and sterilization implemented.

Conventional pure steam generators with z. T. multi-stage high distillation columns and the use of cyclone separators represent cost-intensive designs more compact tube bundle steam generators are known. The majority of the used Pure steam generator z. B. for pharmaceutical purposes work with oversized Steam boilers to prevent major pressure fluctuations in the boiler and the Heat capacity essentially from that in the boiler Take out the amount of water.

Task and description of the procedure

In conventional steam generators, pressure fluctuations, delay in boiling and overdistillation / carryover of increased flow velocity inorganic and organic distillation / condensate residues arise.

A major advantage of low temperature matrix distillation (NTMD) is that so far the temperature gradients arising from the heating of liquids are prevented and thus a much more even and effective separation between liquid and Gaseous phase is made possible. This can lead to overdistillation / carryover of inorganic and organic distillation / condensate residues be excluded. The steam generated is much more homogeneous and  drier than previously achievable with conventional steam generators. Furthermore, with the Low temperature matrix distillation (NTMD) significantly reduces the residence time the steam and in comparison with conventional pure steam generators with z. T. multi-stage high distillation columns and the use of cyclone separators much more compact, less expensive design enables. The procedure is not too compare with technical solutions that are one or more in a row switched filter systems a steam cleaning and homogenization for temporary Use comparable steam quality. The crucial basic principle The method is that a pre-filtration according to (DE 196 40 034.1), optionally with a Combined inert gas separation, an inert matrix is connected upstream, in which due to the existing specific heat capacity, the distillation within the matrix is brought about. This prevents the majority of those bound in cell assemblies Pyrogens and prions did not reach the MDA. Organic and inorganic Distillation / condensate residues can temporarily be one of the inert matrix Subjected to high temperature treatment over 200 ° and at the end of the complete Decontamination process by reversing the steam flow direction from the system be rinsed out.

The water supply is controlled depending on pressure and temperature. Another major advantage of the NTMD is that even in the low temperature range (40 ° - 80 ° C) high-purity steam can be generated for cleaning purposes temperature-related drying and / or protein coagulation of residual contaminants avoid. Furthermore, by an intermediate NTMD cleaning solutions decontaminated and regenerated or operated in a cycle. Just that enables high-quality, low-cost pure steam generation in negative pressure an effective, water-saving and therefore economical cleaning (including Demineralization and disinfection). In particular, hidden cavities that can be used for a secure spray, rinse and immersion disinfection without pressure change treatment were unsuitable, can now be validated cleaned and disinfected. additionally steam cleaning enables cleaning performance up to the level of porous goods Pyrogens. In addition, whole quarantine can be done with this NTMD procedure containers are cleaned and disinfected.

In addition to the much lower water requirement and the possibility with the Matrix steam distillation, even in circulatory systems, separates organic, to achieve pyrogenic and prion contaminants that are low in these Temperature ranges below 100 ° C can not be inactivated without chemical additives can. Furthermore, NTMD enables a short residence time of the steam and thus a continuous flow operation for the economical generation of pure steam and ultrapure water e.g. B. for injections. Between individual batches of the company in the Low temperature range below 134 ° C is recommended, including the complete system all contaminated piping systems, filter elements and valves in one pass with final overpressure steam sterilization over 2.7 bar overpressure (over 140 ° C) with a temperature holding time of at least 20 minutes. It also makes sense Use NTMD at pressures well over 5 or 10 bar. This precaution applies especially when reprocessing instruments after invasive surgery detected TSE infection carriers. Preferably, the goods are first cold, liquid cleaning z. B. via spray arms (rotating, as usual in a dishwasher) subjected. For this purpose, hollow bodies are preferably resistant to negative or positive pressure To provide coupling, the safe flow of all relevant components with steam and  Ensures cleaning fluid.

The spray arms and hollow body couplings are preferably pulsating Connect pressure lamps with an adjustable pressure up to 110 bar. The single ones Spray heads can be designed on the principle of a steam milling machine. The Functionality of the system can be controlled by sequential activation of each one Spray nozzles can be checked via the existing pressure sensor during the process. The instruments can preferably be cleaned by pre-cleaning initially with a max. 40-45 ° C warm pyrogen-free cleaning solution with and without chemical additives over the pressure-resistant coupling pieces the hollow body instruments be flushed out. At the same time, the additional external cleaning of the Instruments over rotating spray arms. The processes of the Pre-cleaning repeated at least in 2 cycles in a vacuum. For rinsing (for Removal of cleaning solutions, alkalis and acids used) are included in the processes pyrogen-free water and / or steam repeated. Circuits with a integrated sterile filtration and / or NTMD to prevent contamination of the Exclude line system up to the spray heads.

Claims (16)

1. The method characterized in that for the production of liquid and gaseous distillates for the supply of cleaning, disinfection, sterilization and distillation equipment, the distillation in a steam generator, which consists of a monolithic or poured gas-permeable matrix preferably made of porous metals and / or ceramics , he follows. 2. The method according to claim 1, characterized in that the matrix Distillation chamber only partially filled and / or at least partially the temperature and pressure conditions of the distillation chamber is exposed. 3. The method according to claim 1 and ff., Characterized in that for the production of liquid and gaseous distillates in the distillation chamber before sterile filtration or is connected downstream. 4. The method according to claim 1, characterized in that the overpressure and / or Vacuum is worked. 5. The method according to claim 1 and ff., Characterized in that for increasing and / or Lowering the boiling temperature of the aqueous solutions additives are added. 6. The method according to claim 1 and ff., Characterized in that to increase the Cleaning performance Cleaning additives, detergents and / or alcohols added become. 7. The method according to claim 1, characterized in that the matrix of porous or spilled materials such as B. metals or ceramics or exists. 8. The method according to claim 1 and ff., Characterized in that phosphoryl-releasing test stains or a comparable usable apathogenic indicator of the whole production or individual Manufacturing process sections of liquid or solid medical products, Food or other materials and goods are added. 9. The method according to claim 1 and ff., Characterized in that the distillation in Single and multi-stage vacuum and overpressure. 10. The method according to claim 1 and ff., Characterized in that the hollow body by a positive or negative pressure connection to the steam penetration in the process checked together or individually. 11. The method according to claim 10, characterized in that the hollow body by a Positive or negative pressure connection based on the cleaning performance in the process of soiling / test soiling can be checked. 12. The method according to claim 1 and ff., Characterized in that for desalination the steam extraction increases the pressure and in the opposite direction the desalination with and done without chemical additives. 13. The method according to claim 1 and 12, characterized in that the matrix region, in which the distillation and thus the salt enrichment takes place, exchangeable and / or can be regenerated separately. 14. The method according to claim 1, 12 and 13, characterized in that for desalination  a distillation stage is connected upstream. 15. The method according to claim 1 and ff., Characterized in that the matrix simultaneously is electrically / magnetically charged for desalination. 16. The method according to claim 1 and ff., Characterized in that the matrix Sterile filtration is connected upstream.