MICLAB-015 Microbiological Data Recording Procedure

It is the responsibility of the person conducting the test to record all the information into either electronic record keeping system or the relevant books.

The primary function of the Micro Laboratory record keeping system is to record the tests and test results collected by the Microlab.  The documentation system should provide the ability to trace and trend results in a timely manner and review the testing and release status of products.

The type of information should be recorded may include: raw material tests, sterility tests, parametric release products, non-sterile tests, bioburden tests, water testing, preparation of media, autoclave charts, machine and line steaming charts, fallout plate results, bacterial endotoxin tests and biological assay tests.

1. Micro Lab Logbooks

Microlab Autoclave Log and Maintenance Record Book – Details of all cycles by the Microlab Autoclaves, including Date, Cycle number, Temperature employed, Time employed and contents.  Also information on problems experienced in the operation of either autoclave and maintenance details are recorded in these books.  All entries must be initialled.

pH meter Logbook – Information to be recorded includes Date calibrated, Date cleaned and Date electrode renewed.

Biological Attest Incubator Logbook – Information to be recorded for the Attest Ethylene Oxide and Steam Sterilisation incubators includes results of a temperature check on the incubators, at time of use.

Sterility Test Room Logbook – Details of any alterations to the Sterility Test Room are to be recorded in this book, e.g. change of mop heads, intensive cleaning or fumigation.

Microorganism I.D Logbook – Information to be recorded using form includes, test date, ID#, gram stain, sample, details/date, tested by.

Raw Material samples from Warehouse Logbook – Used to record the delivery of samples from the Warehouse to the Micro Lab.

2. Production Logbooks

Environmental Monitoring Plate Sample log for Microbiology Laboratory

Sterility, Pyrogen and Fallout Plate Sample Log for Microbiology Laboratory

Chart Log for Microbiology Laboratory

Non-sterile and Raw Material Sample Log for Microbiology Laboratory

Vessel, Line and Bioburdens Log for Microbiology Laboratory

3. Sterilization Logbooks

Steaming Charts logbook, keeps a log of all the results of steaming of the machines.

4. Comment Books

Environmental Monitoring – Comments Book

Any relevant information concerning Environmental Areas such as leaks, spills or other incidents plus any additional testing conducted, and why, is recorded with the full date and initials of the operator at the conclusion of the comment.

5. Files

Environmental Results (Surfaces) Sterile Areas – Surface sample results from Glass & sterile areas.

Environmental Results (Air File) Sterile Areas – Air sample results from Glass & sterile areas.

Environmental Results (Surfaces) Non-sterile – Surface sample results from sterile production and Microlab areas.

Environmental Results (Air File) Non-sterile – Air sample results from sterile and Microlab areas.

Environmental Tracking Forms – is used to keep track of when and who conducts the testing and recording of an environmental area.  All entries must be initialed and dated.

Personnel Monitoring Log Sheets – Sterile areas – Files used to store the forms that log personnel monitoring conducted by sterile operators.

Environmental Recovery Forms – Forms used by production to document steps taken after an environmental breach.

Recommissioning of Environmental Areas – Information to be filled out to recommission a graded room.

Fridge Monitoring & Store Room Temperature file – All microlab fridges and media store areas.

Water Testing Reports file – Water sampling summaries and Water graph summary reports.

Bioburden Reports file -Microbiological status of batches before filtration or sterilization and Bioburden analysis of filled containers.

Personnel Monitoring Reports Glove Print Plates file – Sterile Area personnel – finger dab results.

Personnel Monitoring Reports Uniform Plates file – Sterile Area personnel – uniform plate results.

LAL-GEL Clot Test Session Results file – Results of Gel-Clot test session using form. Information to be recorded includes, the batch number, date tested, tested by, product, container & size, dilution, results, passed, standards, controls and reagent details.

Microlab Minutes and General file – Contains the Minutes to Monthly Microlab Meetings and any other information relevant to the Microlab.

Monitoring Results for Sterility Test Session file – Results of fallout plates exposed during sterility test session, results of finger print impressions by the Operator, the Operator’s name, the Laminar air results (1000L), the Laminar bench surface result from a contact plate and the Sterility room number to be recorded plus personnel monitoring.

Environmental Monitoring Investigations file.

Compressed Air and Nitrogen Testing file.

Summary Review of Environmental Monitoring file.

In-Process Media Run file – that details all relevant information to a media run (MICLAB 035)

Aseptic Media Fill Validations file – Completed process validation reports on the media runs carried out on the filling machines.

Quality Control Certificate file – Certificates of Analysis on purchased prepared media, Millipore Steritest Units, IPA Filters and Anaerobic Indicators.

Sample Identification Checklist file.

Equipment Log Files – All Microbiology Laboratory equipment is listed in these Files, a separate file is kept for old equipment.  Maintenance and calibration schedules and records, if relevant, are detailed in this file.

Production Team files.

Goods Receipt File.

Suppliers Correspondence File.

Micro Lab database files

Housekeeping Reports – Contains information that are used to conduct weekly housekeeping audits.

Disinfectants and Waste Tank Test File – Results of Disinfectant and Waste Tank Tests.

Validated Sterile Operators File – Contains information that are used in the validation process.

Sterile Entry Practical Entry Training Records.

Sterile Training Information and Assessment Sheets File.

Sterile Training Program and Masters File.

6. Autoclave Chart Files

Microbiology Laboratory Autoclaves charts and print outs (shows both temperature and pressure readings).

7. Steaming Chart Files

Sterile Filling machines – Machine chart recording of steam sterilisation cycle, (when applicable).

Vessel and Line Charts  – Printout.

8. Computer Systems

Sterility Test and Microbiology Laboratory Incubators & Sterility Room Air Pressures

Temperatures of the Microlab incubators are monitored and recorded.  Sterility incubators and Sterility Room air pressures should be linked to an external alarm for accurate surveillance.

9. Summary of Changes