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. 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 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. 11.2.1 Patheon is responsible for ensuring that adequate cleaning is carried out between batches of different products to prevent contamination. This is achieved and verified with the overall cleaning validation program on site.
Cleaning Validation. Avecia shall provide to PharmAthene details of all other products manufactured in the same stream of Avecia’s facility as any Drug Substance Produced under this Agreement, including dosage information, and shall demonstrate successful cleaning verification.
