Cleaning Validation. Bachem shall be responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent cross contamination Bachem shall also be responsible for conducting cleaning verification or validation as appropriate (to ensure the integrity of all products, including critical carry-over from similar batches).
Cleaning Validation. Fresenius is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. The cleaning process will be validated before the first PRODUCT Batches are made for TransMedics. TransMedics shall review the cleaning validation on an audit basis. Data should be available to support the campaign of batches of the same product, and the type of cleaning that will be performed in between manufacturing of the same product.
Cleaning Validation. 13 11.3 Equipment, Computer, Facility and Utilities Qualification......................................... 13 11.4
Cleaning Validation. DSM is responsible for ensuring that adequate cleaning is carried out between lots of different products to prevent contamination. Data should be available to support the campaign of lots of the same product and the type of cleaning that will be performed in between manufacturing of the same product. Barrier will provide information (i.e. LD50, toxicity, solubility, lot size, fill volume, product min dose/70Kg patient) and establish cleaning limits with DSM assistance.
Cleaning Validation. BIRI is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. BIRI is responsible for having approved cleaning procedures for Product(s)
Cleaning Validation. Nastech is responsible for ensuring that adequate cleaning is carried out between lots of different products to prevent contamination. Data shall be available to support the campaign of lots of the same product and the type of cleaning that will be performed in between manufacturing of the same product. A documented protocol to show that each cleaning validation was successful will be issued by Nastech. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Cleaning Validation cleaning validation will be required throughout the process, including dedicated and non dedicated equipment i.e. general equipment, mixing and holding tanks, filling line. Specific cleaning method is available at Gentium and will be transferred. Batch Release – Subcontractor (QP) performs the batch release to Gentium, issuing Certificate of Analysis and Certificate of Compliance. The Batch Release to the market has to be performed by Gentium.
Cleaning Validation. DPI is responsible for ensuring that adequate cleaning is completed to prevent contamination. Data should be available to support the campaign of batches of the same product and the type of cleaning that will be performed in between manufacturing of the same product. AMAG will provide information (i.e. [***], solubility, batch size, fill volume, [***] to establish cleaning limits.
Cleaning Validation. 10.2.1 SYNCO is responsible for ensuring that cleaning processes are validated for all products produced in the SYNCO facilities and that adequate cleaning is carried out on components and equipment between batches to prevent contamination at SYNCO. Chiron is responsible for the validation of the cleaning processes related to Chiron's products.
10.2.2 CHIRON and SYNCO will cooperate to establish cleaning limits for the facilities involved in the manufacture of product.
10.2.3 The cleaning procedures and analytical methodology will be jointly reviewed. SYNCO and CHIRON will review cleaning procedures and testing methodology pertaining to product.
Cleaning Validation. All cleaning procedures of production equipment
