Cleaning standard operating procedure

The overall cleaning process comprises the soiled equipment, a cleaning method with the associated cleaning equipment, a cleaning agent(s), and process parameters (time, temperature, etc.). These factors should all be captured in a cleaning standard operating procedure (SOP). 

In any setup, it is paramount that the electrodes get cleaned regularly. The minimum frequency, e.g., once a week, should be described in the instrument standard operation procedure (SOP), but for some methods or samples more frequent cleaning is necessary. An example is the determination of the enantiomeric purity of adrenaline in local anesthetic solutions. The samples are isotonic and contain high concentrations of local anesthetics (5—20mg/ml). The determination concerns very low concentrations of adrenaline (typically 5 pg/ml of 1-form and only a few percent of that of the d-form) and the samples are therefore injected undiluted. Furthermore, relatively high concentrations of cyclodextrin are present in the BGE. Eong sequences therefore require electrode cleaning for every sequence and this is thus described in the method procedure. ... 

Laboratory apparatus should be periodically inspected, cleaned, maintained, and calibrated according to standard operating procedures. 

Standard operating procedure should define cleaning of process equipment and facilities. Operators should be trained in cleaning SOPs. 

The written Standard Operating Procedures required under 58.81(b)(ll) shall set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment, and shall specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written standard operating procedures shall designate the person responsible for the performance of each operation. 

Finally, during the qualification of the facility, all systems are tested, calibrated, and cleaned. The mechanical and service infrastructure must be qualified. The operational qualification will involve practice runs. All documentation must be finalized. This includes standard operating procedures, batch records, and equipment logs. 

Availability of standard operating procedures. This section requires the executors to verify and list applicable operational, preventative maintenance, calibration, and equipment cleaning procedures that are available. 

The procedural controls applicable for the preventive maintenance and repair of the hardware provide a mechanism for anticipating problems and, as a consequence, possible loss of data. Modem hardware usually requires minimum maintenance because electronic circuit boards, for example, are usually easily replaced and cleaning may be limited to dust removal. Diagnostic software is usually available from the supplier to check the performance of the computer system and to isolate defective integrated circuits. Maintenance procedures should be included in the organization s standard operating procedures. The availability of spare parts and access to qualified service personnel are important for the smooth operation of the maintenance program. 

Manufacture of any pharmaceutical product must satisfy the requirements of Good Manufacturing Practice (GMP). These are basically that the equipment be properly designed, maintained and cleaned, that Standard Operating Procedures are written, approved and followed, quality to be independently monitored and that all personnel... 

The equipment used in a study should be tested on site before it is used the first time, within certain time intervals, and after repairs. It should be periodically inspected, cleaned, maintained, and calibrated according to the Standard Operating Procedures (SOPs). Records of these activities should be maintained. 

Sources of Information for Material Balance. There are many sources of information in establishing material balances for the various unit operations within the plant. Data may be obtained from sample analysis and measurements of raw input materials, raw material purchase records, material and emission inventories, equipment cleaning and validation procedures, batch composition records, product specifications, operating logs, standard operating procedures, and manuals. 

Before execution of the cleaning validation, the cleaning procedures should be in the form of approved standard operating procedures (SOPs). These procedures should be detailed enough to be reproducible. Parameters such as detergent type, detergent concentration, exposure time, rinse temperature/rinse time, and water pressure/flow rate should be included in the procedure. The final rinse is usually performed with water for injection (WFI). The production operators should be trained in these procedures and their training should be documented. 

The fermentation department should monitor and control the COD/ BOD of its liquid waste to the sewer. Procedures for cleaning up spills and reporting should be Standard Operating Procedure. A primary aeration basin will reduce the COD to 80-90 ppm. Secondary aeration lagoons will reduce the BOD to acceptible levels which have no odor. 

It is current good manufacturing practice for a manufacturer to establish and follow written standard operating procedures to clean production equipment in a manner that precludes contamination of current and future batches. This is especially critical where contamination may present direct safety concerns, as with a potent drug such as a steroid (e.g., cortisone, and estrogen), antibiotic, or sulfa drug, where there are hypersensitivity concerns. 

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