Cleaning products checking labels

People are the principal source of contamination in clean room operations. All personnel involved throughout the development and production of a parenteral product must be aware of the factors that influence the overall quality of a product as well as the factors on which they directly impinge. It is of particular importance that production personnel be properly trained so that human error is minimized. They should be made aware of the use of the products with which they are involved and the importance of following all procedures, especially proper aseptic techniques. Procedures must be set up to verify that the product is being manufactured as intended. After manufacture of a batch, production tickets must be carefully checked, sterilization charts examined, and labels verified for correctness and count. 

Contamination is controlled at multiple levels in a pharmaceutical plant. It starts with a clean, well-maintained facility. Raw materials are labeled, checked, and segregated at storage. Equipment is cleaned and tested for cleanliness prior to being used. Personnel are to follow procedures as written in SOPs. Samples and products are clearly labeled and stored. Flows of materials, equipment, personnel, tools, and wastes are controlled. 

Quite often the containers of an adhesive or sealant will bear a special label stating the safe upper limit of temperature during storage. Containers should be checked when received to see if such a label is present. As soon as the container is received, the user should place an additional label on it, stating the date received and the date when the shelf life will expire. This will provide useful information when it comes to scrapping old product or maintaining the freshest product in inventory. A record should also be kept of the manufacturer s lot number for possible future reference. Containers should be kept tightly closed, and labels should be kept clean for proper identification. 

Before a packaging operation begins, checks should be made to ensure that the work area and equipment are clean and free from any product, product residues, materials, labels or documents not required for that operation. The record of these checks should form part of the batch packaging documentation. (Ref. 3.36). 

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