10.12 Daily Question – Short answer question; a reward is given for every correct answer

The last edit to this post was made by zdl1966 on 2017-10-12 at 18:37. 1. The requirements of GMP regarding equipment and materials subject to control are as follows: ① All pipes, fittings, filters, nozzles, etc., in water and gas systems should be made of high-quality austenitic stainless steel； ②Other materials chosen must be corrosion-resistant and rust-proof. 2. The properties of materials include their mechanical properties, physical properties, chemical properties, and processability. 3. Mechanical properties: Refer to a material’s ability to resist deformation or failure under external forces, including strength, hardness, elasticity, plasticity, and toughness. Strength: refers to the ability of a material to resist external loads without failing or breaking. The strength parameters of materials at room temperature are yield strength and tensile (compressive) strength. The ratio of yield strength to tensile (compressive) strength is called the yield strength ratio. Parts made from materials with a low yield strength ratio possess higher safety and reliability, but if the yield strength ratio is too low, the utilization rate of the material’s strength decreases. An excessively high or low yield strength ratio is not suitable. Hardness: The local resistance of a solid material to mechanical forces applied from outside; it is an indicator that reflects the combined properties of a material’s elasticity, strength, and plasticity.

GMP requires that the materials of equipment must not have an adverse effect on the quality of drugs. Production equipment that comes into direct contact with drugs must be corrosion-resistant, and must not undergo chemical reactions with the drugs, absorb them, or release substances into them.

The material selection for equipment must be strictly controlled. Components in direct contact with drugs should be made of materials that are non-toxic, corrosion-resistant, and do not undergo chemical reactions with drugs or absorb them.

GMP requires that the materials of equipment must not have an adverse effect on the quality of drugs. Production equipment that comes into direct contact with drugs must be corrosion-resistant, and must not undergo chemical reactions with the drugs, absorb them, or release substances into them.

The material selection for equipment must be strictly controlled. Components that come into direct contact with drugs should be made of materials that are non-toxic, corrosion-resistant, and do not undergo chemical reactions with drugs or absorb them

1. All pipes, fittings, filters, nozzles, etc. in water and gas systems should be made of high-quality austenitic stainless steel； 2. Other materials chosen must be corrosion-resistant and non-rusting.

①All pipes, fittings, filters, nozzles, etc. in water and gas systems should be made of high-quality austenitic stainless steel.② If other materials are used, they must be corrosion-resistant and non-rusting.

. II. All parts of the equipment that come into direct contact with drugs shall be made of materials that do not react chemically with the drugs, do not release particles, do not adsorb drugs, and do not deform or deteriorate after disinfection or sterilization.

1\ All pipes, fittings, filters, nozzles, etc. in water and gas systems should be made of high-quality austenitic stainless steel； 2\ Other materials chosen must be corrosion-resistant and non-rusting.

①All pipes, fittings, filters, nozzles, etc. in water and gas systems should be made of high-quality austenitic stainless steel； ②Other materials chosen must be corrosion-resistant and rust-proof.