Sterility Test System
Compliance with regulatory requirements in ChP, USP, EP and JP.
SM86 sterility test system is used for sterility test in sterile product.It can work with all kinds of closed canister. Many types of sterile products can be tested with the SM86 sterility test system, including:
â?? LVP(Large Volume Parenteral) in Glass bottle, plastic bottle, soft pouch, etc.
â?? Injection in Ampoule and vial, and freeze-dried powder
â?? Insoluble powder
â?? Medical devices
â?? Preloaded syringe
It is to test whether testing sample contains microorganisms. The microorganisms present in the sample are captured on the microporous membrane in the closed canister by the action of directional peristaltic pressure from the SM86 pump device. Rinsing membrane to remove the bacteriostatic ingredient if samples included. Appropriate medium is pumped into each canister separately to promote the growth of the captured organisms. The canisters are incubated and examined for contamination in accordance with the relevant pharmacopoeia.
Sterility Test Closed Canister Sterility Test Closed Canister is used for pharmaceutical product sterility test by the membrane filter method Which produced in high strict condition. Working together with sterility test device. Sterilization EtO Sterilization Gamma irradiated sterilization Feature Adopt all imported original pharmaceutical grade material, without chemical releasing. Ultrasonic welding process, avoiding side leakage accident. Chosen membrane avoiding adsorption of drugs. Designed wrench style clasp, easy to control the flow rate. Connected single use sealing lock clasp in the tube, easy to control. Sealing stopper for top and bottom designed with two wings of ergonomics. Imported adhesive paper of sealing package, avoiding false positive result by sterilization and false negative result by EtO. Double package including certain negative pressure, eliminating the risk of false positive and false negative. Each set of closed canister package all have sterilization indicator card inside, giving visual clearly instruction of its sterilization result. Having 50ml cycle scale and 100ml alarm line in the canister body. The color of wrench style clasp is same as single use sealing clasp in one tube which easy discriminates different tubes.
Embed Sterility test pump (SM86) This type is mainly applied for Aseptic Isolator. It can work with types of canister and various of testing samples. It is designed to be integrated and the top part is sealed into the chamber of isolator for sterility test, and the bottom is exposed from isolator and be electricity parts. Main parts: Pump device, pump head, screen, bottle holder, drain tray, speed control and footswitch. Technical feature 1. SS304 material, easy to clean and disinfection. 2. Drain tray can be hung on or lay on the table. When hung on, more than 180 degree angle for choice to meet the demand for different operation habit of operator. 3. The drain tray can be disassemble to be drain tray container and support. Drain tray container is designed to be integral whole processing molding with big internal arc angle, good for liquid out and clean & disinfection. 4. Palm design bottle holder for put bottles. its hook are for soft pouch. 5. Bottle holder can 360 degree swing and up and down to adjust suitable position. 6. Screen present current speed and time & date. 7. Footswitch can help operator control the operation.
STERRAD Cassette features proprietary technology utilizing low-temperature hydrogen peroxide gas plasma for terminal sterilization of medical devices. Their sterilant comes in an easily loaded cassette format that delivers a predefined quantity of hydrogen peroxide per cycle to achieve sterilization both conveniently and effectively. Best of all, each cassette is a closed system, sealed for the operator's safety, and has a chemical indicator on the packaging in order to detect any leakage of sterilant during transportation. Finally, unlike some sterilization modalities, ASP's uniquely bar-coded STERRAD System cassettes can be transported via ground or air shipment. Product Features: STERRAD system sterilant cassettes made by ASP The pre-loaded cassette provides an easy and highly effective way to sterilize Each STERRAD sterilant cassette is a closed system and sealed for the operator's safety Each STERRAD sterilant cassette is individually wrapped with an external leak monitor to detect any leakage during transportation
Guedel Airways / Oropharyngeal Airways Product Code: MED 110 Specifications: Sterile, individually packed in peelable pouch pack Size/Strength: 000, 00, 0, 1, 2, 3, 4 & 5 Description The oropharyngeal airway devices are made from the raw material of PE. Rounded atraumatic edges. Made from semi-rigid nontoxic Polyethylene. Bite block to prevent biting of tongue and airway occlusion. Smooth airway path for easy cleaning. Color coded for easy identification of sizes Individually packed
Ambu Bag Resuscitator Product Code: MED 119 Specifications: Sterile, individually packed in a polybag Size/Strength: Infant Description 250ml. self-inflating double ended silicone bag with mounts incorporating Reservoir valve and side feed oxygen inlet Type â??Lâ?? nonrebreathing valve with pressure limiting device wherein it will open if the inspiratory pressure is more than 40cms of water Size 0 Clearhood facemask with silicone cuff 2mtrs oxygen enrichment tubing & 2600ml Reservoir bag all in a carrying case.
3 Way Stop Cock Product Code: MED 154 Specifications: Sterile, individually packed in peelable pouch pack Description Three arm handle for facilitating smooth and easy operations. Minimum residual fluid volume. Stop cock having two female luer lock ports and one male luer lock Port with rotatory lock for safe connection to another device. Made from non-toxic, medical grade
Infant Feeding Tube Product Code: MED 184 Specifications: Sterile, individually packed in peelable pouch pack Size/Strength: 4-10(length 52 cm) Description Manufactured from nontoxic, medical grade PVC compound. Distal end is smooth coned shape for nontraumatic intubation. Two lateral eyes for efficient drainage. The tube is marked at 20 cm from the distal end for accurate placement into the abdomen. Radio opaque line provided throughout the tube for X-ray visualization. Proximal end is provided with luer mount for connection with feeding device. Also, available with graduation. Marking from the tip 5 cm to 40 cm.
Breathing Bags Product Code: MED 119 Specifications: Sterile, individually packed in a polybag Size/Strength: 0.5ltrs, 1.0ltrs, 2.0ltrs, 3.0ltrs Description comfortable in usage, these feature thin, durable designs and can be made available in different finish sizes to pick from to fit patientâ??s specific needs. hourglass-shaped breathing bag also helps in reducing the fatigue of the hands as well as also provide firm grip to the hands. The tri-pleat design also offers a better fit over patient's face. Breathing Bags are the devices finding application that temporarily assist patients to breathe. These Anaesthesia Bags bags are used with face mask that is placed over patient's mouth and nose and is connected to oxygen source for providing complete breathing ease. These bags are squeezed and this leads to oxygen being pushed into patient's lungs
Infant T- Piece anesthetic circuits Product Code: MED 120 Specifications: Sterile, individually packed in a polybag Size/Strength: Pediatric Description Rendell Baker Soucek Facemasks Sizes 1 & 2 15mm/22mm Angle Mount 15mm Ayre's T 15cm X 11mm Corrugated Rubber Hose with 15mm M/F Hose Mount pair 0.5 Ltr. Breathing Bag with Bleed Valve 1.5 mtrs PVC Tubing for fresh gas supply 23mm Male Plug-in Mount 23mm/23mm Female/Female Circuit Adaptor Carrying case Jackson Rees Pediatric Circuits offered comprises a unique water trapper so as to ensure of excellent drainage. With the option of the device being ported for temperature as well as capnography, the accessory support makes it as a flexible option to use. We also ensure that all offered accessories are well approved for quality as well as safe usage during pediatric general anesthesia application. Offering low resistance and minimal dead space, these also offer ideal positioning so as to maximize moisture collection. sterile and pyrogen free.
