Toxicity of Active Materials

In the preceding chapter, solubilities of the APIs were presented. Likewise, the toxicities of the same active materials are shown in the matrix below. Toxicity was taken from the material safety data sheets of the respective materials. Acebutolol hydrochloride Acetazolamide Albendazole Aluminum hydroxide Alprostadil Azithromycin dihydrate Betamethasone valerate Bacitracin USP Bacampicillin hydrochloride Bisacodyl LD50 88.0 g kg intraperitoneal mouse LD50 20.0 g kg oral rat LD50 10.0 g kg oral...

Solubility of Active Materials in Water

In this section, the solubilities of over 200 active pharmaceutical ingredients (APIs) are presented. The matrix shows the extent of solubility of the most commonly used APIs in the manufacture of medicines. Again, the purpose of this matrix is to help in the selection of worst-case products, containing these APIs for cleaning validation, based on their solubility in water or alcohol. Practically insoluble in water, soluble in alcohol Freely soluble in water and in alcohol Very slightly soluble...

Cleaning Validation Protocol for Encapsulation Machine

Your Company's Logo ) Company's Name machine and model Country 20.8.1 Cleaning Validation Protocol for Encapsulation Machine (Type A) The objective of this protocol is to demonstrate that the cleaning procedure No. ABC-001 will successfully and consistently reduce the level of residues to a predetermined level of acceptability, so as to prevent contamination (product or cleaning process related) from adversely affecting the safety and quality of the next product manufactured. This protocol will...

Cleaning Validation Protocol for Powder Filling Machine

Your Company's Logo Company's Name CLEANING VALIDATION PROTOCOL Equipment Name Production Manager Approved by Production Director Authorized by QA Director Company, Country Signature & Date The objective of this protocol is to demonstrate that the cleaning procedure No. ABC-001 for powder-filling machines will successfully and consistently reduce the level of residues to a predetermined level of acceptability, so as to prevent contamination (product or cleaning process related) from...

Change Control Revalidation

11.1 A change control system is in place to ensure that all changes that might impact the cleaning process are assessed and documented. Significant changes should follow satisfactory review and authorization of the documented change proposal through the change control procedure. Minor changes or changes having no direct impact on final or in-process product quality should be handled through the documentation system. The review should include consideration of revalidation of the cleaning...

Cleaning Validation Protocol for Fluid Bed Dryer

Swab Sample Location For Fluid Bed Drier

Your Company's Logo Company's Name Written by Validation Officer Reviewed by QA Manager Production Manager (Tablets) Approved by Production Director Authorized by QA Director Company Name and Country Signature & Date The objective is to demonstrate that the cleaning procedure ABC-001 will successfully and consistently reduce the level of residues to a predetermined level of acceptability, so as to prevent contaminants (products or cleaning process related) from adversely affecting the safety...

Detergents

9.7 When detergents are used in the cleaning process, their composition should be known to the user and their removal should be demonstrated. The manufacturer should ensure that they are notified by the detergent supplier of any changes in the formulation of the detergent. 9.8 Detergents should be easily removable, being used to facilitate the cleaning during the cleaning process. Acceptable limits should be defined for detergent residues after cleaning. The possibility of detergent breakdown...

Sampling Precautions

Before taking the sample, wear the following Open the tank outlet valve slowly and collect the sample in labeled bottles as stated in Table 39.5.1. Equipment used in three strengths of biological products Formulation tank, FT-01 Formulation tank, FT-02 Mobile holding tank, MT-01 Sterile filling tank, SFT Sampling and testing plan (formulation tank FT-01) 5-7 pH unit NMT 1.1 jas cm NMT 500 ppb Not detected less than the limit of detection 2.85 jg mL NMT 10 cfu 100 mL Less than or equal to the...

Protocol for Manufacturing Vessel

Your Company's Logo Company's Name The objective of this protocol is to demonstrate that the cleaning procedure will successfully and consistently reduce the level of residues to a predetermined level of acceptability for the 1000-L manufacturing vessel. This protocol will cover cleaning of the semisolid manufacturing vessel (Figure 36.1.1) for the following cream and ointment products (Table 36.1.1). The above-mentioned products are divided into different categories (group) based on water...

Cleaning Validation Product Grouping Matrix Syrup

Clobutinol HCl Orciprenaline sulfate 802 mg kg oral rat 5538 mg kg oral rat Glyceryl guaiacolate Chlorpheniramine Batch Maximum Size Usage per (L) Day Loratadine Ambroxol Furosemide Multivitamins Triprolidine HCl Pseudoephedrine HCl Pseudoephedrine HCl Dextromethorphan Pseudoephedrine HCl Hyoscine-N-butyl bromide Ketotifen fumarate Cetirizine HCl Ferrous sulfate Loratadine Ambroxol HCl Furosemide Vitamin A Vitamin D Vitamin E chloride Cetylpyridinium Tyrothricin Chlorhexidine 75GG 3.75 mg 9G mg...