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Latex formula for making bladder blood pressure measuring devices ABSTRACT TRIAL PRODUCTION OF RUBBER FOR SPYGMOMANOMETER FREE FROM NITROSAMIN AND PROTEIN ALLERGEN IN FACTORY SCALE. The rubber for sphygmomanometer in this study is: bulb, bladder, and tube which made from irradiated natural rubber latex in factory scale production at PT. Sugih Instrumendo Abadi Padalarang. The irradiated natural latex is prepared by 7 rays' Co radiation vulcanization on natural rubber latex at the doses of 25 kGy, and 3 phr (part hundred ratio of rubber) was added by antioxidant then it was made rubber for sphygmomanometer (bladder, bulb, and tube) by coagulant dipping method. Three important factors: heating temperature (90 ° C and 100 ° C), heating time (4,8,12,116,20,24 hours), and leaching technique (water, solution of ammonia and KOH) has, and the physical and mechanical properties of rubber film (modulus, tensile strength, elongation at break, hardness) has been evaluated. The results show that heating temperature at 90 ° C, and heating time on 8 hour then leached in 0,5% solution of ammonia or KOH are the optimum condition processing. By using this optimum condition the tensile strength of film is 24 MPa, modulus 600% 2.0 MPa, elongation at break 1000%. Hardness is 30 Shore A, with the extractable protein content is around 72-110 nig, and nitrosamine content is not detected (zero). The value of ELISA test method for absorbance of a sensitive human serum again protein allergen is zero (negative), and the response of rubber serum again skin through SPT method is zero (negative), which means that rubber for sphygmomanometer is free from nitrosamine and a protein allergen. Key words: Sphygmomanometer, nitrosamine, protein allergen, irradiated natural rubber latex Preliminary Tensimeter (Sphygmomanometer) is an instrument that can be used to measure arterial blood pressure indirectly (non-invasively) with the help of a stetoscope. This instrument is equipped with a manometer, a packaging container, which is the outside of the tensimeter instrument for placing other parts of the equipment. This packaging container contains, among others: rubber balls, rubber hoses, and bladders wrapped in kai A case that had occurred in America around 1980-1985, namely a nurse who often used a tensimeter, had malignant cancer in her body. After researching it, it turned out that the cause was the nitrosamine from the tensimeter ball which the nurse often used. Eventually the nurse claimed tens of millions of US dollars to tensimeter manufacturers [6]. Another case that has been reported in several publications, is not only nitrosamines but also allergen proteins that can cause allergies in the human body. For example, some workers in hospitals in Jakarta, who use gloves made of natural rubber or factory workers who are in direct contact with natural rubber, show that around 3% of these workers are allergic to natural rubber [7], even if people who are allergic to natural rubber operated on by medics who used rubber finished goods of natural rubber (gloves, condoms and catheters) can cause. With these incidents, since 1987, Europe has limited the content of nitrosamines in rubber finished goods, for example in baby pacifiers, a maximum of 1-10 ppb, and the World Health Organization (WHO) since 1999 has drafted restrictions on extracted protein content ( protein that causes allergies) in rubber products, eg gloves maximum 150 pg / g How is the chemical formula for making latex for medical devices There are actually 3 types of latex that can be used for the production of bladders, balloons, and hoses for tensimeters, namely: concentrated natural latex or concentrated natural latex, chloroprene latex (neoprene), and irradiated natural latex, which by itself the three types of latex have different specifications - different Natural rubber latex consists of rubber particles and a non-rubber material. Natural rubber particles contain polyisoprene, which when irradiated will occur a cross-linking event, meanwhile the non-rubber material in the latex consists of various amino acids containing thiol compounds, as well as aromatic and aliphatic amino acids, carbonyl groups and olifenic groups. As a result of irradiation, it will experience degradation, so there will be various kinds of radicals or can also experience deamination, deamidation, decarboxylation, oxidation of S-H groups, reduction of S-S groups, changes in amino acid side chains and addition / reduction of peptide chains. This event is followed by changes in biological, biochemical, and physicochemical properties, thus forming new products that are easily soluble in water [20-21] When the irradiated rubber film is washed with water, the new compound will come out of the rubber film, consequently the protein value, fat, and the rubber film carbohydrates decreased. Latex Compound Formulation In general, the method of formulating latex compounds for rubber finished goods by means of sulfur vulcanization must be added with vulcanizing agents (sulfur), activating agents (zeng oxides), accelerating agents (carbamate compounds, thiazoles, aldehyde-amines, thiazol sulfoamides, thiophosphates, guanidine, thiourea, or thiocarbonyl sulfenamide) and anti-oxidants (phenyl or amine compounds) into concentrated latex. Because the four types of substances have the potential to produce compounds that are toxic, carcinogenic and allergic [22], it is recommended that they use as little as possible. Table 3 presents the composition of sulfur vulcanized latex compounds and irradiated natural latex used to manufacture bladders, balls and hoses on a factory scale. From this table it shows that only one type of chemical is needed for radiation vulcanization, namely antioxidant phenol compounds with low toxicity and allergy type IV, while for sulfur vulcanization there are 4 types, namely activating agents, accelerators, antioxidants, and sulfur vulcanizing agents. which according to Makuuchi [23] these materials are sufficiently low to high risk of toxicity, type IV allergies, and carcinogens (cancer causing) in the finished rubber products produced. So when viewed from this formulation, irradiated natural latex compounds in addition to more efficient chemicals, it is also a low risk of toxic materials derived from antioxidants. To overcome the toxicity and allergies of type IV from antioxidants, BHT is used as an antioxidant ingredient for irradiated natural latex compounds, because BHT is a non-toxic antioxidant and type IV allergy. In particular, the manufacture of bladders comes from two materials, namely natural and synthetic (neoprene bladder). These two basic ingredients use the same dispersion at different levels. The formula for making natural bladders is as follows: 1. Preparation of natural latex dispersion Yellow package creation Sulfur = 750 gr BHT Yosmox / Vulcanox = 1250 gr Tamol / Vultamol NN 9104 = 50 gr Bentonite / Molding = 13 gr The yellow package material is mixed with water in a 2 liter bucket, White Package Creation ZDBC / LDB (from bayer) = 1250 gr ZDEC / LDA (from Bayer) = 500 gr ZnO (from Bayer) = 750 gr Tamol / Vultamol = 50 gr Bentonite / Molding = 13 gr The white package material is mixed with water in a bucket of 0.5 liter, The two packages are put in the ballmill tank and then grinded for 20 hours 2. 200 liters of concentrated latex that has been brooded for 1 week, given texapon and KOH according to the MST table for then stand by for 2 hours. 3. The rolled yellow package formula is included in 200 liters of concentrated latex. Then on stand by for 1 hour 4. Then put a white package and an additional 200 liters of concentrated latex that has been creased. So that the total concentrated latex is 400 liters 5. Then we get a mixture of natural latex For the manufacture of synthetic latex The difference is in the yellow white package making: Yellow package creation Sulfur = 2464 gr BHT Yosmox / Vulcanox = 4520 gr Tamol / Vultamol NN 9104 = 376 gr Bentonite / Molding = 46 gr The yellow package material is mixed with water in a 2 liter bucket, White Package Creation ZDBC / LDB (from bayer) = 2464 gr Orotan = 752 gr ZnO (from Bayer) = 12300 gr Triton = 400 gr Bentonite / Molding = 100gr 1 synthesis package formula package consists of a mixture of 2 buckets yellow package + 4 buckets white package. To control mixing, enter the formula or water using a 2 liter pitcher.

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