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Laboratory Safety
Marlia Singgih WibowoSchool of Pharmacy ITB
Topics in Laboratory Safety
Risk evaluation : pharmaceutical consideration, mikrobiological consideration, risk quantification, risk managementmikrobiological Audit : Laboratory safety in mikrobiology, training, auditorClassification of microorganisms based on risk ofinfection, distribution and its virulent according toWHOManagement of BiosafetyPrevention and management of accident in Microbiology Laboratory
Mikrobiology Laboratory
Good Laboratory Practices (GLP)
PrepareManageAuditReport
Why Audit?
Pharmaceutical Industry has to guarantee their products to be Safe, Qualified and BeneficialAudit is part of Quality Management SystemAs a Control Function against contamination and improvement
Classification of deficiency (penyimpangan)
Critical DeficiencyMajor DeficiencyOther Deficiency
Critical Deficiency
Very likely to cause risk to patient, can cause side effect, accident, or deathPossibility : potency of product is not suitable, not pure, unclear identity, or the product is not safe to be consumedProducts should be withdrawn from market
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
Other Deficiency
Deficiency which including foliation of GMP (Good Manufacturing Practise)Not directly influence the product qualityExample : Lack of Control Card in the Warehouse, etc.
Audit in Microbiology Laboratory
Microbiology Laboratory’s role in Pharmaceutical Industry is checking the safety of raw material, intermediate and end-productAlso in training and education for the employees, training in Good Contamination Control Practice (GCCP)
GCCP (Good Contamination Control Practice)
Development of Formula, Process of formulation Design of FacilitiesProblem solvingRisk Assessment (interpretation of microbiological data in relation to products and its risk to patient
Topics related to audit in microbiology laboratory
Security of AccessDesign and lay-out of laboratoryGood HousekeepingValidation of analytical methodsValidation of equipmentsMaintenance and Calibration of equipmentsMedium for microbial cultures
Preparation of media
Preparation of raw material Preparation of glasswares and apparatus for making mediaWeighing and Mixing Sterilization of mediaMixing and dispensingLabeling and StorageQuality ControlSupplier /Vendor
GLP (Good Laboratory Practice)
Receiving Sample and preparation of sampelProcedure of analysisData Management, review and approval
HACCP
Hazard Analysis of Critical Control Points(HACCP) is a method to guarantee product quality and safetyThis 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
HACCP
Each point of any process is specific in general to have a chance to be contaminated by microorganismRisk of every microbial contamination should be defined and identifiedProcess to be controlled including: preparation, manufacture, distribution, storage, and usage.
Laboratory Safety
Building : Roof and walls Rooms : Floor, door, window, furniture, cleaning Equipments and Instruments : installing, and cleaningPipes, sewageRaw Materials, intermediates, end product WaterPackaging materials Laboratory coats, hygiene of workersDocuments
Risk ranking
Risk level = probability of occurrence x severity of occurrenceDegree of probability :5 : Definite or will be happen4 : Very Likely to happen 3 : Likely to happen2 : Very Rarely 1 : Unlikely
Degree of Severity5 : Fatal4 : 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
Risk Level
Risk level 20 – 25 : Catastrophic (prohibited to be done)Risk level 15 – 19 : Serious (need special assessment)Risk level 10 – 14 : Significant (need general assessment)Risk level 4 – 9 : Minor (general assessment)Risk level 1 – 3 : Trivial (no need any written assessment)
Klasifikasi “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
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)
Pathogenic microorganisms
Assignment :
Summarize some examples of microorganisms which are including in Hazard 1, 2, 3, and 4.