Manufacturing process of a RH pdgf-bb Gel (becaplermin) for cutaneous application suitable for Wound Healing

摘要

Manufacturing process of a Gel For Skin application suitable for Healing wounds, which comprises the following steps: 1) preparing the Drug Substance: 1.1) release the drug substance is kept at a temperature of 2oC to 8oC, 1.(2) schedule the laminar flow Hood (Class 100) According to Standard Operating procedure that includes cleaning of all surfaces with 70% Isopropyl alcohol, 1.3) transfer the contents of the containers to a plastic container of 10 liters autoclaving in Bell F Luxury and laminar mixing for 5 min at 10 min, 2) preparation of the buffer: 2.1) add the required amount of water for injections to the Stainless Steel Tank for the preparation of the buffer, 2.2) add the pre weighed amounts of parabens to water for injections for its dissolution by maintaining a temperature of 80oC and cool then the solution (40 To appropriate (7 degrees C, 2.3) add the following excipients pre weighed the buffer Tank in the following Order: a) Methylparaben Propylparaben, 2.4), (b) mixing the components dissolved in the water for injections to maintain the temperature at 80u00bacu00ba + 5C and Cooling the solution to appropriate (7 degrees C, 2.5) add the following excipients pre weighed the buffer Tank in the following Order: a) b), Sodium Chloride, SODIUM ACETATE TRIHYDRATE, l-lysine hydrochloride (c), (d) and (e), glacial acetic acid, m-cresol 99%, 3) formulation of the gel to add: 3.1) The weighing Hopper in the room The previously Heavy amount of Sodium CarboxyMethyl Cellulose (NaCMC), 3.2) transferring the closed hopper to the room but the preparation buffer and connect the Assembly of mixed fast is connected by a pipe to turboemulsificador Ross located in the room of the formulation of the Gel (Class 10000), 3.3) Pump Buffer Solution through a 0.45 mm Filter cvhl durapore (F - 209) that is connected to a Filter cvgl durapore sterile 0.22 m (F - 210) in a Homogenizer mixing fast is connected to the turboemulsificador, 3.4) transfer approximately 50 kg of this buffer and add the NaCMC from the hopper to the Homogenizer by Aspiration using Buffer Solution as vehicle, transfer the remaining 3.5) buffer solution by mixing the Quick mounting turboemulsificador where continues the process of homogene Introduction to eliminate agglomerates, 4) added the active Principle: 4.1) transfer to a Glass Stainless Steel (T - 103) under laminar flow in the room of thawed the certain amount of the active ingredient, 4.2) carry the Glass PEAR gel formulation to the room and place it on the Assembly of active principle, 4.3) transfer in the P pulses The principle Active Filtering turboemulsificador mixing for 90 min, 100 min, 4.4) by Vacuum defoaming passages and Layers of nitrogen for about 45 minutes, 5) download: 5.1) pressurize the turboemulsificador with nitrogen and download content in Stainless Steel Tank maintenance, 5.2) control in samples taken during the transfer process, the following parameters: a) uniformity of content = relative Standard Deviation less than 15%, (b) pH = 5.5 to 6.5, viscosity = 40000 to 100000 CPS, bioburden = less than 10 cfu / g, 5.3) transfer the Storage Tank to room temperature while maintaining a Intermediates to 2oC to 8oC (Class 10000) wait for 6) filling, filling, and packaging.