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of product is not suitable, not pure, unclear identity, or the product is not safe to be consumedProducts should be withdrawn from market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.