You dont have javascript enabled! Please enable it! LAB-105 Laboratory Housekeeping and Glassware Cleaning Pharmaceuticals quality assurance & validation procedures GMPSOP

LAB-105 Laboratory Housekeeping and Glassware Cleaning

DepartmentLaboratoryDocument noLAB-105
TitleLaboratory Housekeeping and Glassware Cleaning
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date:

1.0 DOCUMENT OWNER

Laboratory/Quality Manager

2.0 PURPOSE

The purpose of this document is to establish guidelines for the laboratory housekeeping and glassware cleaning in the Quality Control Laboratory at a GMP/GLP facility.

3.0 SCOPE

This procedure applies to general glassware cleaning, laboratory housekeeping and housekeeping inspections carried out by the QC Laboratory personnel.

4.0 RESPONSIBILITY \ BUSINESS RULES

4.0 All Laboratory personnel involved with glassware cleaning, laboratory housekeeping and housekeeping inspections must follow this procedure.

4.1 The Laboratory Manager, Team Leaders and all laboratory staff are responsible for ensuring that the laboratory housekeeping is maintained to an acceptable level of GMP/GLP.

5.0 PROCEDURE

5.1 Housekeeping

5.1.1 General Housekeeping Requirements

5.1.1.1 Laboratory housekeeping should be maintained to an acceptable level of GMP/GLP at all times.

5.1.1.2 Doorways, aisles and traffic ways should not be obstructed.

5.1.1.3 Work areas (e.g., workbench and instrument room) should be maintained clean and clear of chemicals and apparatus when not required. Any spillages onto the bench top or floor should be wiped up as soon as they occur.

5.1.1.4 All storage areas including, but not limited to, the document filing area, stationery storage cabinets, clean glassware cabinets and chemical storage cabinets should be maintained clean and tidy.

5.1.1.5 The filing compactus are locked if unattended.

5.1.1.6 All gas taps and water outlets should be turned off when not in use.

5.1.1.7 Fume hoods should be maintained in an orderly state at all times.

5.1.1.8 All water baths and ultrasonic baths should be emptied, scrubbed and filled with fresh water on a weekly basis.

5.1.1.9 Laboratory wastes should be emptied on a regular basis as per SOP LAB-040 Laboratory Waste Management

5.1.1.10 All waste paper should be placed into the waste paper bins. Note: The Contract Cleaners should empty waste paper bins.

5.1.2 Chemicals and Reagents

5.1.2.1 All laboratory chemicals and reagents must be stored in the designated locations as per SOP LAB-110 Safety Procedure in Laboratory.

5.1.2.2 All laboratory chemicals and reagents must be labelled properly as per SOP LAB-115 Use and Control of laboratory Chemical Materials.

5.1.2.3 Chemical and Reagent bottles should always be cleaned if the contents have been spilled down the sides.

5.1.3 Emergency Facilities

5.1.3.1 The emergency facilities including, but not limited to, the fire extinguishers, the safety showers, the eyewash fountains, the emergency exit signs and the spill kits (i.e. chemical spill kit, mercury spill kit) should be maintained at functioning state.

5.1.3.2 Access to the laboratory emergency facilities should be maintained clear at all times.

5.1.4 Washing-up Area 

5.1.4.1 The washing-up area should be maintained clean at all times.

5.1.4.2 The designated areas for clean glassware and dirty glassware should be labelled clearly.

5.1.5 Housekeeping Inspections

5.1.5.1 Housekeeping inspections should be performed once a month by the laboratory personnel as per the monthly laboratory housekeeping schedule.

5.1.5.2 Housekeeping inspections should be carried out in all Laboratories and follow the Laboratory Housekeeping Inspection List (Appendix 1) to ensure that all requirements specified in Section 5.1.1, 5.1.2, 5.1.3 and 5.1.4 have been met.

5.1.5.3 The housekeeping auditors should record the results of the housekeeping inspection in the Form-425 Housekeeping Audit Checksheet for Laboratory.

5.1.5.4 If there is any non-compliance noted, the designated person should take action to rectify it, and indicate the completion of the corrective action on the Form-425 Housekeeping Audit Checksheet for Laboratory with signature/initial and date.

5.1.5.5 The inspector should verify the completion of corrective actions, sign Form-425 Housekeeping Audit Checksheet for Laboratory, and file it in the Housekeeping folder located in the compactus.

5.2 Glassware

5.2.1 Dirty Glassware Collection 

5.2.1.1 All dirty glassware must be rinsed thoroughly by the analyst.

5.2.1.2 All dirty glassware with a volume of less or equal to 2 L should be placed into the wash trolley.

5.2.1.3 All dirty glassware with a volume of more than 2 L should be placed into the designated area in the washing-up area.

5.2.1.4 All broken and chipped glassware should be disposed of as per SOP LAB-040 Laboratory Waste Management.

5.2.2 Glassware Cleaning

5.2.2.1 The Laboratory Attendant should collect the dirty glassware and remove the label if required.

5.2.2.2 Place the dirty glassware in the Miele dishwasher, operate the dishwasher for a cleaning wash cycle.

5.2.2.3 The clean glassware should transfer from the dishwasher to the drying oven.

5.2.2.4 The dried clean glassware should be stored in the designated location when not in use.

5.2.3 Dirty Pipette Collection

A Pipette Holder is made up of two parts:

a. The main body containing a pyroneg solution; and  

b. The pipette holder.   

5.2.3.1 Pipette holders containing a pyroneg solution (made by 1 level measuring spoon of pyroneg dispersed in water) are placed in the designate locations. Note: The pyroneg solution should be changed on a weekly basis by the Laboratory Attendant, and it should be labelled as per standard procedure.

5.2.3.2 The Laboratory Analysts must rinse the pipettes with water after use, and gently place the dirty pipettes tip up into one of the pipette holders.

5.2.3.3 When the pipette holder is full, the Laboratory Attendant should lift the holder from the solution and drain the pipettes into a bucket.

5.2.4 Pipette Cleaning 

5.2.4.1 The Laboratory Attendant should check dirty pipettes for greasy substances.  If any grease is noted or the pipette appears unclean, it must be rinsed first in hot water, and then rinsed in Chloroform (in a fumehood) to help remove the grease before washing in the dishwasher.

5.2.4.2 Change the washing tray in the dishwasher to the pipette washer tray.

5.2.4.3 Place pipettes from the pipette holders into the stainless steel basket from the Miele dishwasher, tips down.

5.2.4.4 Place 1 spoon of Deconex washing powder into the detergent dispenser and snap shut the lid.

5.2.4.7 When wash cycle is complete, transfer the pipettes to a clean pipette holder, tips up.

5.2.4.8 Immerse the holder into a 100% Alcohol solution until air bubbles disperse.  The Alcohol solution should be labelled properly and changed every 3 months by the Laboratory Attendant.

5.2.4.9 Remove the holder from the Alcohol and drain the pipettes.

5.2.4.10 Leave the pipettes in washing-up area until dry.

5.2.4.11 When the pipettes are dry, transfer to the dedicated pipette drawers.

6.0 DEFINITIONS / ACRONYMS

None

7.0 REFERENCES

LAB-040 Laboratory Waste Management
LAB-110 Safety Procedure in Laboratory
LAB-115 Use and Control of laboratory Chemical Materials
Form-425 Housekeeping Audit Checksheet for Laboratory

8.0 SUMMARY OF CHANGES

Version # Revision History
Lab-105 New

 

Appendix 1:   Laboratory Housekeeping Inspection List

Emergency Facilities are maintained at functioning state with clear access for:

–           Fire Extinguishers

–           Safety Showers

–           Eyewash Fountains

–           Emergency Exit Signs

–           First Aid Kit

–           Chemical Spill Kits

–           Mercury Spill Kit

General Safety – Doorways, aisles and traffic ways are not obstructed;

Wastes (including chemical and broken glass) are disposed of as required;

Instruments are calibrated up to date (if applicable) or a DO NOT USE sign is affixed, the water contained in water baths is clean, and the associated logbooks are completed;

Random check on the chemical reagents and solutions, reference standards are properly labelled, within the expiry dates, and stored correctly in the designated location in logical order;

Fume hoods are clean and orderly, and free from un-required equipment;

All logbooks are completed when required;

All laboratory work areas and storage areas (including cabinets under work benches) are clean and orderly;

All samples under testing or 3 month retention are stored properly; 10. Office areas are clean and orderly.