Maintenance Cleaning

Assign responsibility for administration, maintenance, cleaning and general housekeeping... 

X. COLUMN AND GEL MAINTENANCE. CLEANING, REGENERATION, AND STORAGE METHODS... 

Facilities and Equipment System This includes (1) buildings and facilities along with maintenance (2) equipment IQ, QQ, calibration, maintenance, cleaning, and validation of cleaning processes and (3) utilities such as HVAC, compressed gases, steam, and water systems. 

Training records for all individuals (production, maintenance, cleaning) involved in the hll should be reviewed to assure proper training was provided. 

Table 2-5 lists tolerances for micropipets from one manufacturer. As internal parts wear out, both precision and accuracy can decline by an order of magnitude. In a study17 of 54 micropipets in use at a biomedical lab, 12 were accurate and precise to <1%. Five of 54 had errors >10%. When 54 quality control technicians at four pharmaceutical companies used a properly functioning micropipet, 10 people were accurate and precise to <1%. Six were inaccurate by >10%. Micropipets require periodic calibration and maintenance (cleaning, seal replacement, and lubrication) and operators require certification.18... 

All supporting documentation (validation SOPs, demonstration documents, etc.) in place Appropriate operating procedures (manufacturing, maintenance/preventative maintenance, cleaning, etc.) in place Document maintenance (number, filing, retrieval) in place... 

Process equipment (design, construction, maintenance, cleaning, calibration, and computerized systems)... 

Specification references, including purchase orders and contract numbers Verification of calibration of critical installed components Verification of procedures (e.g., operation, maintenance, cleaning, change control)... 

The critical part of documentation is the preparation of the SOP. SOP is a set of guidelines written to define the activity of a specific operation. In addition to preformulation, other operations, including quality control procedure, materials handling, manufacturing process, equipment calibration and maintenance, cleaning, stability storage, and evaluation, should be prepared before their occurrence. The SOP must be reviewed and issued by the management responsible for the operation. In addition, periodic review and revision of the SOP should be conducted. 

Logbooks should be kept with major and critical equipment and should record, as appropriate, any validations, calibrations, maintenance, cleaning, or repair operations, including dates and the identity of the people who carried these operations out... 

---