Machinfabrik Private Limited Rabale, Navi Mumbai, Maharashtra

All pharmaceutical production processes require a stable & consistent supply of quality controlled water for applications ranging from non-critical processes to product formulation. The most important equipment in any pharmaceutical plant manufacturing injectable solutions is the WFI Still. Our WFI Still produces distillate that meets the current U.S and European pharmacopeia for Water for Injection guidelines systems equipped with a range of features to ensure that your installation and qualification is quick & trouble-tree and that your WFI production remains efficient and reliable. Machinfabrik WFI Still is designed with efficiency in mind. Since the system recovers the latent heat of vaporization occurring within its own process to heat feed water and uses the feed water as the primary source of cooling, our system is an energy and money saving ingenuity.

Introduction Applications Features Manufacturers and processors of packaged foods are continuously developing innovative packaging materials to differentiate their product in the minds of the customer. Another priority is to develop packaging keeping in focus long shelf life of the product. This packaging material requires very gentle and accurate processing during heat treatment or sterilization processes necessitating the use of systems alternate to conventional Steam Retorts. Machinfabrik offers Water Immersion Sterilizers to address this need. The Water Immersion process is similar to a saturated steam process to the extent that the product, which is submerged in water, is completely isolated from the influence of air. But, it is different from Saturated Steam because air can be introduced into the vessel during sterilization. This introduction of air provides the over pressure necessary to ensure integrity of the packaging material. The heated air agitates the water as it flows to the surface and serves to pressurize the process load. Our systems can also be incorporated with rotary operation to accelerate heat transfer to the product and ensure heat penetration to the coldest spot of viscous products.

Hospital infection control is a serious problem, which no Hospital Administrator can afford to ignore. Proper attention needs to be focused on the system of Cleaning, Disinfection, Packaging, Sterilization and Storage of different surgical appliances and instruments. The continuous advancements made in the field of Bio Medical Engineering have resulted in the development of a range of surgical appliances and instruments with very intricate and delicate profiles. Any sterile supply chain must have a system, which can clean and disinfect these components with a very high degree of accuracy and repeatability. Machinfabrik’s “DISINFECTOMAT” Washer Disinfectors have been designed with just that in mind. The system is not only flexible but also very user friendly to take care of your every need. HIGH IMPACT CLEANING SYSTEM: The DISINFECTOMAT is provided with three rotary spray arms with six spray nozzles. The design and location of the nozzles ensure that every surface of the load is uniformly cleaned. The arms rotate due to water pressure there by eliminating any mechanical drive system. FLEXIBLE LOADING SYSTEM: AUTOMATIC DETERGENT DOZING: IN BUILT HEATING SYSTEM:

Cleaning is an integral component of virtually all instrument-reprocessing guidelines. If labeled for reuse, instruments require manual pre-cleaning, using a brush and detergent solution, to remove gross patient debris. Because complex instruments may remain contaminated with patient debris even after manual brushing, most reprocessing guidelines recommend using ultrasonic energy to remove fine debris that might otherwise be inaccessible and remain on the instrument. Unless the cleaning process effectively removes microorganisms and organic debris from even the most inaccessible surfaces of a contaminated instrument, the sterilization process is likely to fail. Developing more advanced cleaning technologies that can adapt to even the most complex surgical instruments and clean their most inaccessible internal surfaces is crucial to the prevention of patient infection.

a compact, reliable and efficient table top sterilizer is an asset for any healthcare institution – large or small. A small institute may have only this system as its primary sterilization equipment. Whereas a large institute may select the table top sterilizer as a local system for express or urgent sterilization. machinfabrik’s table top sterilizer has design and construction features at par with large hospital sterilizers and offer the user the same process assurance and safety. The table top sterilizers are suitable for sterilization of solid, wrapped and tubular components and an optional liquid program. These sterilizers use microprocessor design, providing smart logic control for precision temperature monitoring and a full range of settings for diagnostics, drying and pre-programmed sterilization presets. The main feature is a powerful vacuum system for thorough inside-out sterilization of tubal instruments.

STORAGE ACCESSORIES For a comprehensive infection control philosophy proper procedure and practices should be followed for the storage of clean and sterile components and parts. A range of flexible and user friendly systems are provided for this purpose.

The production programs in the pharmaceutical industry are aimed at maximum safety, top quality and high economy. This applies in particular to the sterilization process. Steam Sterilizer continues to be one of the ancient but widely used sterilization techniques in the Life-Science & HealthCare Industry. The process systems now have to meet the most exacting demands for temperature and pressure / Vacuum control and process documentation. A sterilization systems represents Therefore, Machinfabrik takes measures to ensure that our Sterilizers provide and life cycle economy. Every Sterilizer is produced to your specifications and needs. Flexible options allow selection of the right equipment for each specific sterilization load and packaging. Solid materials.   Porous materials like garments, fabrics, etc.   Closures, Vessels, Machine and change parts.   Empty Glassware, Utensils, Instruments.   Solutions in glass ampoules, vials & bottles.   Filters and respective accessories

Steam-Air Terminal sterilizers are designed primarily for sterilizing products with flexible and delicate packaging that require counter pressure throughout the sterilization phase. Another significant advantage is that the product is dry and ready for further the handling immediately after the unloading. In a steam sterilizer, the temperature and pressure relationship is always pre-defined. In steam-Air sterilizers a separate medium is used for heating (steam) and pressurizing (air) and thus the relation can be varied. Due to this we can achieve a chamber pressure which is higher or lower than the corresponding steam pressure for a given temperature. Hence this system helps to overcome the drawbacks associated with conventional steam sterilization systems. For plastic containers or pre-filled syringes the internal pressure must be balance such that there is no net pressure differential across the container and/or closure or else there is a risk of compromising the container and/ or disrupting the closure e.g. excessive stopper movement in a pre-filled syringe An intelligent control system constantly adapts the pressure in the chamber to the pressure in the containers. This protects sensitive material to be sterilized against deformation. Steam and Air have different densities and will “stratify” if not mechanically mixed. (i.e., the heavier air will sink to the bottom). Here a fan and ducting is used to create a circulation pattern and maintain a homogenous environment. Ampoules.   Pre-filled syringes.   Vials.   Ointment tubes.   Glass Bottles.   Blister packed containers.   Intraocular lens   Soft bags   Closures, Vessels, Machine and change parts

As the pharmaceutical industry continues to grow and change, Machinfabrik strives to deliver superior quality products that are manufactured in accordance with cGMP. By choosing Machinfabrik Pure Steam Generator you are taking a proactive step in eliminating instance of contamination thus safe guarding your company and the end user from products that could be potentially harmful. The sterilization process at a pharmaceutical industry requires high quality pure steam with accurate pressure control and fast response times. Machinfabrik Pure Steam Generator is capable of producing pyrogen-free sterile pure steam that when condensed meets all USP requirements for use in steam sterilizers, critical area humidification and routine SIP.

Over the years Machinfabrik has developed cutting edge solutions for processing systems and as results our engineers have gained deep and meaningful insight into process and cycle development for a wide range of products and packaging materials. . With a view to ensure that our customers can benefit from this know-how, Machinfabrik has a Process Development Autoclave where customers can bring their product and packaging material and we assist you in developing the right process / cycle ideal for your need.

CONTROL & PACKAGING TABLE The table has stainless steel top for preparing packs and has shelves fitted on a S.S. Stand. The Operators can easily operate on both sides of the table.

Steam Sterilizers continue to be one of the most ancient but widely used sterilization techniques in the Healthcare Industry for effective infection control. A Sterilization system also represents the most important investment in a CSSD. At Machinfabrik we ensure that our Steam Sterilizers provide true value to Healthcare Professionals with regards to design, performance and life cycle economy. Flexible options allow users the selection of the right equipment to satisfy their needs. PULSATING DEEP VACUUM To sterilize fabrics and wrapped instruments, mechanical air removal from the chamber is important. This ensures uniform penetration of steam. A high performance and efficient vacuum pump takes care of this by means of automatic pulsation prior to treatment. This ensures removal of all air pockets from the load. The post vacuum treatment ensures vacuum drying of the load before unloading. The system is equipped with various programs, which offers full range of cycle combinations to cater to all your needs. Six preprograms for instant selection are provided.

The principle that terminal sterilization provides a higher degree of sterility assurance than aseptic processing is well understood and leads regulatory agencies around the world to require that if the product can be terminally sterilized it must be. The technology of hot water sterilization with counter pressure has been developed specifically for the terminal treatment of solutions in sealed containers. The working principle is based on automatic counter pressure by injection of compressed air into the chamber during the entire cycle, to minimize the differential pressure across the containers generated by exposure to heat. The water shower over the product ensures that a uniform temperature distribution is maintained throughout the chamber during the sterilization phase. The high rate of water circulation and the two-stage water distribution system ensures accurate and homogenous temperature distribution in the product to be sterilized. Since the water comes into physical contact with the container the heat transfer is more efficient and the process efficiency is not affected by air pockets. The pressure in the chamber is continuously adapted to the internal pressure of the containers and the entire process can be controlled easily and accurately . Ampoules   Blow Fill Seal containers.   Vials   Closures, Vessels, Machine and change parts.   Polypropylene bottles   Glass Bottles   Soft bags

TABLE TROLLEYS Fabricated from hygienic stainless steel, the Table Trolley is provided with two shelves with a side support for transportation of soiled or cleaned material within the CSSD. The Table Trolley is provided with revolving and lockable nylon castors for smooth and easy movement.

All areas of production in any pharmaceutical industry increasingly demand qualification and documentation of the cleaning processes. Years of experience with international customers has made Machinfabrik a reliable partner for validated cleaning. Our washers have been designed to meet and exceed the growing cGMP requirements of the Biopharmaceutical industry. Working in cooperation with users, our equipment has been developed to satisfy the unique demands and stringent regulations of the industry. We can provide a complete solution supported by need analysis and system design to suit your requirements. Our systems are based on compatible modular units that can quickly be integrated and installed to form complete customized solution based solely on your needs. All machines are based on high-performance cleaning modules a rinsing system and an integrated air-drying system.

In the Food and Beverage industry various products require drying to ensure required shelf life. Food products require gentle drying to preserve the products original shape, color, taste & nutrients and for these applications freeze drying process is ideally suited. Some foods freeze dry very well, but not all food is suitable for freeze drying. Small fruits and vegetables can be easily freeze dried, whereas whole fruits and large vegetables would not be suitable, although they can be freeze dried if cut into small pieces first. This also applies to meat; small chunks of meat freeze dries well, but larger fillets need to be cut into pieces. Meat and seafood also require cooking before freeze drying. For some foods freeze drying is not cost-effective. Machinfabrik designs and manufactures freeze drying machines for sale worldwide. The process typical operating sequence of the freeze drying process is as follows:       Freezing of the product and freeze hold.   Cooling of ice condenser   Evacuation   Primary drying   Secondary drying

A perfect harmony of man and machine All our Loading systems have been designed with two things in mind - People & movement. This makes our design a cut above the ordinary. While moving heavy loads it is important to ensure that movement is easy and strenuous positions are avoided. It is also necessary to factor that people differ in height and strengths. This harmony of letting people handle heavy loads is the central theme of our ergonomic design. Our years of experience in the field of sterilization ensures that we can customize every Loading System to your product. This is particularly important to ensure that each product is handled carefully and placed as per the validated loading pattern. Our design team also carefully considers the interfacing of our Loading system with your material handling philosophy. Last & most important is the interface of the Loading System with the machine to ensure a proper flow and penetration of the sterilizing agent.

Ethylene Oxide Sterilizers are designed to perform low temperature, chemical sterilization treatment of medical and pharmaceutical products sensitive to temperature / humidity. Machinfabrik EO Gas Sterilizers kill the toughest of microbes but are gentle enough to protect the integrity of the product and packaging. A wide range of program options, installation arrangements and loading options increases the versatility. Whether you use external preconditioning and aeration or our unique Combined Process Systems, Machinfabrik can offer customized solutions for your most exacting needs. EO Gas Sterilizers operate with a sterilant which is potentially explosive. Hence these Sterilizers incorporate design features, devices & additional means of protection in order to operate in potentially explosive atmosphere in conformity with the established parameters ensuring a very high level of protection against explosions.

To achieve the objective of delivering quality healthcare at an affordable price and to guarantee a high level of infection control, sterilization of critical medical devices is of paramount importance. EO Gas Sterilizer plays an important role to achieve sterilization at low temperature. Machinfabrik offers three models of EO Sterilizers operating on 100% EO Cartridges. The system is fully automatic and operated by a PLC to ensure high process accuracy and repeatability with focus on the safety of the operator and the environment. The chamber is fabricated from stainless steel and is fitted with one/two doors. An arrangement is provided to humidify the load to ensure that the correct RH is maintained for most effective sterilization. The inbuilt vacuum system which does not require any water generates a deep vacuum so critical to the processing. The system also includes a heating system to accurately maintain the desired temperature, an important parameters for process lethality. A wide range of handling accessories are included to provide the user high flexibility without compromising on the space availability.

TFlexible endoscopy is a common clinical procedure and all patients undergoing it must be protected from infection, which can occur by one of three routes: from patient to patient, from environment to patient or from organisms within the patient’s body It is therefore essential that endoscopes are cleaned thoroughly and correctly disinfected after each use and that the guidelines for cleaning and disinfecting flexible endoscopes are strictly adhered to. Any organic debris left on the endoscope, such as blood or mucus, can prevent adequate penetration of the disinfectant or sterilizing medium and glutaraldehyde, which is the most widely used disinfectant, acts as a fixative on these materials. Failing to clean endoscopes correctly can also result in the instrument channels becoming blocked, leading to inadequate functioning. 

The PYROTECH range of Drying Cabinets are fully automatic, accurate and reliable systems ideally suited for drying of instruments and accessories in a Healthcare facility. The Drying Cabinet is provided with stainless steel trays which can be adjusted to customized locations to offer the user maximum flexibility for handling a wide configuration of loads. Optionally attachments for drying of hoses and tubings can also be provided. The microprocessor controllers allow the user to set the drying temperature and time for best processing results. Various safety interlocks are in place to ensure that the safety of the operator is not compromised.

Sterilization by dry heat has become increasingly popular worldwide due to two reasons first the need to sterilize small objects, particularly ampoules, syringes and secondly for de-pyrogenation of manufacturing apparatus which is not possible in a steam sterilizer. Another advantage of this method of sterilization is that objects which are damaged by water or steam e.g. powder or ointment can be sterilized provided the heat penetrates to all parts of the substance.

Sterilization by dry heat has become increasingly popular worldwide due to two reasons first the need to sterilize small objects, particularly ampoules, syringes and secondly for de-pyrogenation of manufacturing apparatus which is not possible in a steam sterilizer. Another advantage of this method of sterilization is that objects which are damaged by water or steam e.g. powder or ointment can be sterilized provided the heat penetrates to all parts of the substance. The distinctive feature of these sterilizers lies in particle contamination class. We ensure a particle contamination level in the chamber that does not exceed the values prescribed by class 100: not even during transient phase, such as heating and cooling during which the filters can release considerable amounts of practices due to temperature related deformations. Special air flow technique guarantees over-pressure in the chamber throughout the cycle thereby assuring sterile integrity of the load, These sterilizers are designed to meet the stringent requirements of the pharmaceutical and medical device industry and are available in different configurations to meet specific temperature and cycle time requirements. These sterilizers represent the ideal solution for any production where the variability of products, batches and formats does not allow the use of continuous sterilizers such as tunnels.

Sterilization by dry heat has become increasingly popular worldwide due to two reasons first the need to sterilize small objects, particularly ampoules, syringes and secondly for de-pyrogenation of manufacturing apparatus which is not possible in a steam sterilizer. Another advantage of this method of sterilization is that objects which are damaged by water or steam e.g. powder or ointment can be sterilized provided the heat penetrates to all parts of the substance. Contamination seals to prevent air transfer when the sterilizer has been installed between two areas of different contamination levels.