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Vial Filling Machine Validation Pdf Download
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Lean Eatma
Dec 1, 2023, 10:44:26 AM12/1/23
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vial filling machine validation pdf download
Download Zip https://t.co/UjPFyzePT0
MycoScience is an ISO 13485 certified contract manufacturing organization specializing in syringe & vial filling of gels and highly viscous materials for medical device and pharmaceutical applications. We also perform a variety of regulatory testing services with expertise in getting challengeing products to clinical trial stage as soon as possible.
OQ should consider: i) a verification of the software user access policy, with reference to the different possible level of privileges (e.g. administrators usually have the right to modify any parameters, sequences, methods, etc., while operators should have the possibility to run dispensing programs only); ii) a verification of the software sequences, if applicable; iii) a verification of the possible effects of a general power failure (e.g. to check for the presence and / or the need for an UPS; iv) a verification of the calibration status of the major components; for instance, in several dispensing systems, vial filling accuracy is based on balances that weigh the solution during filling operations; balance is in this case a critical component and its performance could be evaluated during OQ by comparison with a calibrated precision balance, using certified weights. Certificate of calibration of the reference balance and weights should not be expired and should be included in the validation documentation. Dispensing systems for individual syringes preparation are preferably based on direct radioactivity determination using dose calibrators: in this case the dose calibrator is the critical component, whose calibration status need to be verified during OQ (see below). One more example of critical components in dispensing systems are the pumps often used to draw / push fluids through tubing assemblies; again, a verification of their calibration (e.g. by measuring dispensed volumes with a reference precision balance) should be performed during OQ; v) a verification of data backup and restore.
As already stated above, Process Validation (PV) should be viewed as the final step of validation, aimed to verify that the preparation process of a RP is capable to prepare the product with the requested characteristics of yield, quality, reliability, safety and efficacy, and that the RP is prepared within a suitable environment, with the necessary safety for the operating personnel and for the product. For the above reasons, it is expected that process validation is being performed when process design, and all the details of the process are adequately known. Preparation of test batches is usually of help and increase the probability of a successful PV. PV should be completed prior to the use of the intended RP in routine clinical activity, while this is not strictly required in case of investigational RPs, where it is considered the possible lack of well-established routine procedures. Objectives and acceptance criteria of PV should be clearly stated. In general, traditional approach to PV consists of the preparation of three consecutive batches of the intended RP, in different days and in the same conditions set for typical routine preparations. This means that starting activity of the radionuclide, reagents / solvents and their quantities, automated system parameters (if applicable), reaction, purification and formulation conditions should be the same as those intended for the routine preparation of the desired radiopharmaceutical. Moreover, the three productions should yield batches with the intended size (e.g. number of vials), and with appropriate labelling and packaging. Every batch of RP prepared accordingly with the above set of conditions should be fully characterized from the analytical point of view, with the aim to verify that the product meet the acceptance criteria as for all the established quality parameters (e.g. radiochemical purity, pH, sterility, radioactive concentration, etc.).
Otherwise, there is no specific requirement to perform the other tests after packaging (including potency). However, you must validate the manufacturing process to demonstrate that the packaging/filling operation does not change the quality of the product (including potency). Your validation data must also show that the homogeneity of a product is maintained by appropriate means throughout the entire filling process for dosage forms such as lotions, creams or other suspensions.
eebf2c3492
vial filling machine validation pdf download
Download Zip https://t.co/UjPFyzePT0
MycoScience is an ISO 13485 certified contract manufacturing organization specializing in syringe & vial filling of gels and highly viscous materials for medical device and pharmaceutical applications. We also perform a variety of regulatory testing services with expertise in getting challengeing products to clinical trial stage as soon as possible.
OQ should consider: i) a verification of the software user access policy, with reference to the different possible level of privileges (e.g. administrators usually have the right to modify any parameters, sequences, methods, etc., while operators should have the possibility to run dispensing programs only); ii) a verification of the software sequences, if applicable; iii) a verification of the possible effects of a general power failure (e.g. to check for the presence and / or the need for an UPS; iv) a verification of the calibration status of the major components; for instance, in several dispensing systems, vial filling accuracy is based on balances that weigh the solution during filling operations; balance is in this case a critical component and its performance could be evaluated during OQ by comparison with a calibrated precision balance, using certified weights. Certificate of calibration of the reference balance and weights should not be expired and should be included in the validation documentation. Dispensing systems for individual syringes preparation are preferably based on direct radioactivity determination using dose calibrators: in this case the dose calibrator is the critical component, whose calibration status need to be verified during OQ (see below). One more example of critical components in dispensing systems are the pumps often used to draw / push fluids through tubing assemblies; again, a verification of their calibration (e.g. by measuring dispensed volumes with a reference precision balance) should be performed during OQ; v) a verification of data backup and restore.
As already stated above, Process Validation (PV) should be viewed as the final step of validation, aimed to verify that the preparation process of a RP is capable to prepare the product with the requested characteristics of yield, quality, reliability, safety and efficacy, and that the RP is prepared within a suitable environment, with the necessary safety for the operating personnel and for the product. For the above reasons, it is expected that process validation is being performed when process design, and all the details of the process are adequately known. Preparation of test batches is usually of help and increase the probability of a successful PV. PV should be completed prior to the use of the intended RP in routine clinical activity, while this is not strictly required in case of investigational RPs, where it is considered the possible lack of well-established routine procedures. Objectives and acceptance criteria of PV should be clearly stated. In general, traditional approach to PV consists of the preparation of three consecutive batches of the intended RP, in different days and in the same conditions set for typical routine preparations. This means that starting activity of the radionuclide, reagents / solvents and their quantities, automated system parameters (if applicable), reaction, purification and formulation conditions should be the same as those intended for the routine preparation of the desired radiopharmaceutical. Moreover, the three productions should yield batches with the intended size (e.g. number of vials), and with appropriate labelling and packaging. Every batch of RP prepared accordingly with the above set of conditions should be fully characterized from the analytical point of view, with the aim to verify that the product meet the acceptance criteria as for all the established quality parameters (e.g. radiochemical purity, pH, sterility, radioactive concentration, etc.).
Otherwise, there is no specific requirement to perform the other tests after packaging (including potency). However, you must validate the manufacturing process to demonstrate that the packaging/filling operation does not change the quality of the product (including potency). Your validation data must also show that the homogeneity of a product is maintained by appropriate means throughout the entire filling process for dosage forms such as lotions, creams or other suspensions.
eebf2c3492
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