Laboratory Safety. Marlia Singgih Wibowo School of Pharmacy ITB

Transcription

1 Laboratory Safety Marlia Singgih Wibowo School of Pharmacy ITB

2 Topics in Laboratory Safety Risk evaluation : pharmaceutical consideration, mikrobiological consideration, risk quantification, risk management mikrobiological Audit : Laboratory safety in mikrobiology, training, auditor Classification of microorganisms based on risk of infection, distribution and its virulent according to WHO Management of Biosafety Prevention and management of accident in Microbiology Laboratory

3 Microbiology Laboratory

4 Good Laboratory Practices (GLP) Prepare Manage Audit Report

5 GLP (Good Laboratory Practice) Receiving Sample and preparation of sampel Procedure of analysis Data Management, review and approval

6 Preparation Preparation of raw material Preparation of glasswares and apparatus for making media Weighing and Mixing Sterilization of media Mixing and dispensing Labeling and Storage Quality Control Supplier /Vendor

7 Why Audit? Pharmaceutical Industry has to guarantee their products to be Safe, Qualified and Beneficial Audit is part of Quality Management System As a Control Function against contamination and improvement

8 Classification of deficiency (penyimpangan) Critical Deficiency Major Deficiency Other Deficiency

9 Critical Deficiency Very likely to cause risk to patient, can cause side effect, accident, or death Possibility : potency of product is not suitable, not pure, unclear identity, or the product is not safe to be consumed Products should be withdrawn from market

10 Major Deficiency Product is out-of-specification The Effect is not directly to patient, but directly to the product quality. In long-term usage with influence the quality and become unsafe Example: broken packaging, etc

11 Other Deficiency Deficiency which including violation of GMP (Good Manufacturing Practise) Not directly influence the product quality Example : Lack of Control Card in the Warehouse, etc.

12 Audit in Microbiology Laboratory Microbiology Laboratory s role in Pharmaceutical Industry is checking the safety of raw material, intermediate and endproduct Also in training and education for the employees, training in Good Contamination Control Practice (GCCP)

13 Topics related to audit in microbiology laboratory Security of Access Design and lay-out of laboratory Good Housekeeping Validation of analytical methods Validation of equipments Maintenance and Calibration of equipments Medium for microbial cultures

14 GCCP (Good Contamination Control Practice) Development of Formula, Process of formulation Design of Facilities Problem solving Risk Assessment (interpretation of microbiological data in relation to products and its risk to patient

15 HACCP Hazard Analysis of Critical Control Points (HACCP) is a method to guarantee product quality and safety This concept is firstly applied at NASA in preparation of astronaut s food, then was applied by FDA-USA to all Pharmaceutical industries and food industries Identification on every critical control points (CCP) to become main activity in HACCP

16 HACCP Each point of any process is specific in general to have a chance to be contaminated by microorganism Risk of every microbial contamination should be defined and identified Process to be controlled including: preparation, manufacture, distribution, storage, and usage.

17 Laboratory Safety covers : Building : Roof and walls Rooms : Floor, door, window, furniture, cleaning Equipments and Instruments : installing, and cleaning Pipes, sewage Raw Materials, intermediates, end product Water Packaging materials Laboratory coats, hygiene of workers Documents

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19 Risk ranking Risk level = probability of occurrence x severity of occurrence Degree of probability : 5 : Definite or will be happen 4 : Very Likely to happen 3 : Likely to happen 2 : Very Rarely 1 : Unlikely

20 Degree of Severity 5 : Fatal 4 : Serious accident (need hospitalized) 3 : Accident with 3 days off 2 : Small accident (only need First Aid) 1 : No Accident A combination of : degree of probability and severity will indicate the risk level (tingkat resiko) in managing the microorganism

21 Risk Level Risk level : Catastrophic (prohibited to be done) Risk level : Serious (need special assessment) Risk level : Significant (need general assessment) Risk level 4 9 : Minor (general assessment) Risk level 1 3 : Trivial (no need any written assessment)

22 Classification of Hazard Hazard 1 : Biological agent which is unlikely causing human diseases Hazard 2 : Biological agent which can cause human diseases but not contigeous to environment. Usually there are some effective treatment available Hazard 3 : Biological agent which is very likely causing severe human diseases and have a risk to spread to environment, but an effective treatment are available. Hazard 4 : Biological agent which is very likely causing severe human diseases and very quickly spreading to environment, no effective treatment available

23 Pathogenic microorganisms All microorganisms, including bacteria, virus, fungi and parasites that categorized in group hazard 2,3 and 4. Examples : (microbes used in EP 1997 for antimicrobial preservatives) Pseudomonas aeruginosa (2) Staphylococcus aureus (2) Candida albicans (2) Aspergillus niger (1) Escherichia coli (1) Zygosaccharomyces rouxii (1)

24 Laboratory facilities are designated as : Basic Biosafety Level 1, Basic Biosafety Level 2, Containment Biosafety Level 3, and Maximum containment Biosafety Level 4. Biosafety level designations are based on a composite of the design features, Construction, containment facilities, equipment, practices and operational procedures Required for working with agents from the various risk groups.

25 Relation of risk groups to biosafety levels, practices and equipment RISK BIOSAFETY LABORATORY LABORATORY SAFETY GROUP LEVEL TYPE PRACTICES EQUIPMENT ====================================================================================== 1 Basic Biosafety Basic teaching, GMT None; open bench Level 1 research work 2 Basic Biosafety Primary health GMT plus protective Openbenchplus BSC Level 2 services;diagnostic clothing, biohazard for potential aerosols services, research sign 3 Containment Special diagnostic As Level 2 plus BSC and/or other Biosafety services, research special clothing, primary devices for all Level 3 controlled access, directional airflow activities 4 Maximum Dangerous pathogen As Level 3 plus Class III BSC, or containment units airlock entry,shower positive pressure suits Biosafety exit, special waste in conjunction with Level 4 disposal Class II BSCs, doubleended autoclave (through the wall),filtered air

26 Classification of laboratory depends on 1. Pathogenicity of the organism. 2. Mode of transmission and host range of the organism. These may be influenced by existing levels of immunity in the local population, density and movement of the host population, presence of appropriate vectors, and standards of environmental hygiene. 3. Local availability of effective preventive measures. These may include: prophylaxis by immunization or administration of antisera (passive immunization); sanitary measures, e.g. food and water hygiene; control of animal reservoirs or arthropod vectors. 4. Local availability of effective treatment. This includes passive immunization,postexposure vaccination and use of antimicrobials, antivirals and chemotherapeutic agents, and should take into consideration the possibility of the emergence of drug-resistant strains.

27 A typical Biosafety Level 1 laboratory (graphics kindly provided by CUH2A, Princeton, NJ, USA)

28 Microorganisms handled in BSL-1 Bacillus subtilis, Naegleria gruberi, E.coli K-12, S.cereviseae Lactobacillus casei, Cephalosporium acremonium, Penicillium camembertii etc

29 A typical Biosafety Level 2 laboratory (graphics kindly provided by CUH2A, Princeton, NJ, USA Procedures likely to generate aerosols are performed within a biological safety cabinet. Doors are kept closed and are posted with appropriate hazard signs. Potentially contaminated wastes are separated from the general waste stream

30 Microorganisms handled in BSL-2 Hepatitis B Virus, Salmonella enteritidis, Toxoplasma gondii, Neisseria meningitis

31 Biosafety level 3 The laboratory is separated from general traffic flow and accessed through an anteroom (double door entry ) or an airlock. An autoclave is available within the facility for decontamination of wastes prior to disposal. A sink with hands-free operation is available. Inward directional airflow is established and all work with infectious materials is conducted within a biological safety cabinet.

32 Microorganisms handled in BSL-3 Mycobacterium tuberculosis, Brucella suis, Virus Encephalitis, Coxiella burnetti