Introduction to Biotechnology Laboratory: Safety, Documentation, and Regulations

What is the purpose of regulatory affairs in biotechnology laboratories?

To dictate safety procedures and protocols for disposal of hazardous chemicals and biologicals, and to improve writing skills and adherence to Standard Operating Procedures (SOPs).

What are some key safety-related materials found in a biotechnology lab?

Eye wash stations, fire extinguishers, fire blankets, emergency gas shut off valve, glass waste, biohazard waste, liquid chemical waste, hazardous chemical storage, spill kit, and first aid kits.

What are some common laboratory materials and equipment used in biotechnology labs?

Micropipettes, microcentrifuge tubes, electrophoresis power supply, balances, spectrophotometers, and incubators.

What is the significance of documentation in a lab notebook for biotechnicians?

It is essential for recording experiments, results, and procedures, ensuring accuracy and reproducibility.

What are the objectives related to math skills for the laboratory?

Identify metric prefixes, convert metric units, convert numbers to/from scientific notation, perform operations in scientific notation, distinguish significant figures, and solve dimensional analysis problems.

What safety equipment should be located in the laboratory according to the notes?

Safety equipment includes eye wash stations, fire extinguishers, fire blankets, and a spill kit.

What is the role of bioinformatics in biotechnology laboratories?

To document and compile information using computers, and to access databases with genomic or statistical information.

What types of waste are managed in a biotechnology lab?

Glass waste, biohazard waste, and liquid chemical waste.

What are Standard Operating Procedures (SOPs) in the context of biotechnology labs?

SOPs are established protocols that dictate how laboratory tasks should be performed safely and consistently.

What is the importance of using a lab notebook in biotechnology?

It helps in maintaining accurate records of experiments, which is crucial for scientific integrity and reproducibility.

What types of storage conditions are mentioned for laboratory samples?

Freezers at -20°C and -80°C, and a refrigerator at 4°C.

What is the purpose of using a micropipette in the lab?

To accurately measure and transfer small volumes of liquid.

What is the function of a spectrophotometer in a biotechnology lab?

To measure the absorbance or transmittance of light in a sample, which helps in quantifying substances.

What are the temperature settings for shaker incubators mentioned in the notes?

28°C and 37°C.

What is the purpose of the MSDS in the laboratory?

To provide safety information about the handling and disposal of hazardous materials.

What is the significance of significant figures in laboratory calculations?

They indicate the precision of measurements and calculations, ensuring accuracy in scientific work.

What is the purpose of gel electrophoresis in biotechnology?

To separate DNA, RNA, or proteins based on their size and charge.

What is the role of a lab report in biotechnology?

To summarize the findings of an experiment, including methods, results, and conclusions.

What is the purpose of solution preparation forms in the lab?

To document the process and components used in preparing solutions for experiments.

What is the importance of safety procedures in a biotechnology lab?

To protect personnel and the environment from hazardous materials and accidents.

What is the function of balances in a biotechnology lab?

To accurately measure the mass of samples and reagents.

What is the purpose of the lab equipment orientation mentioned in the notes?

To familiarize students with the locations and uses of safety-related materials and laboratory equipment.

What is the primary purpose of documentation in a lab setting according to the FDA?

To ensure that all actions and observations are recorded, as stated, 'if it isn't written down, it wasn't done.'

List three reasons why documentation is important in a laboratory.

1. To record actions and observations. 2. To establish ownership for patent and legal purposes. 3. To trace the manufacture of a product.

What should a lab notebook include at a minimum?

1. Date and title page with course name, semester, instructor's name, department, college, institution, and student's name. 2. Table of contents with page numbers. 3. Lab reports with notes and results. 4. Analysis questions for each lab.

What are the general rules for maintaining a lab notebook?

1. Write in ink only. 2. Write legibly. 3. Do not cover or separate information from the notebook. 4. Keep records factual, concise, clear, and complete.

What should be done if an error is made in a lab notebook?

Draw a single line through the error and enter the correction in clear and legible writing.

Why is it important to write legibly in a lab notebook?

Legibility ensures that supervisors and lab mates can read the notes, preventing misinterpretation of important details.

What are the three main parts of a lab report?

1. Pre-lab write-up. 2. Lab notes including SOP, data, and observations. 3. Analysis including calculations and conclusions.

What should be included in the pre-lab write-up?

1. Heading with lab name, date, and student name. 2. Short description of the lab's purpose. 3. Safety information. 4. List of materials and equipment. 5. Detailed steps with spacing between each.

What is the significance of maintaining standard operating procedures (SOP) in lab documentation?

SOPs help ensure consistency, safety, and compliance in laboratory practices.

What should you do if you need to discard data in your lab notebook?

Justify your decision to discard data immediately and in writing.

What is the consequence of not writing down important details in a lab notebook?

It can lead to questions about the work and potentially invalidate results.

How should lab notes be taken during the experiment?

Lab notes should be taken in pen, following the guidelines for legibility and clarity.

What is the purpose of including analysis questions at the end of each lab report?

To evaluate understanding and reflect on the results and processes of the lab.

What is the importance of a table of contents in a lab notebook?

It helps in organizing the notebook and allows for easy navigation to specific sections.

What should never be done with pages in a lab notebook?

Pages should never be folded or stored separately to avoid loss of information.

Why is it important to keep records factual and concise in a lab notebook?

Factual and concise records ensure clarity and reliability of the documented work.

What is the role of the lab notebook in relation to lab reports?

The lab notebook serves as the primary source from which lab reports are derived.

What is the recommended writing instrument for lab notebooks?

Ink is the only acceptable writing instrument; pencil is forbidden.

Why should you not cover information in your lab notebook?

Covering information can obscure important details and hinder the clarity of the records.

What should be done if a lab notebook entry is unclear?

It should be clarified immediately to prevent misinterpretation.

What is the consequence of writing illegibly in a lab notebook?

Illegible writing can render the work essentially nonexistent and lead to misinterpretation.

What is the significance of the FDA's statement regarding documentation?

It emphasizes the critical nature of written records in validating lab work and procedures.

What type of information should be included in lab notes during the experiment?

Standard Operating Procedures (SOP), data collected, detailed observations, and any additional comments.

What must be included in the pre-lab write-up?

Heading, a short description of the purpose, safety information, a list of materials and equipment, and a detailed list of steps.

What is the importance of taking notes during the lab?

You must write down everything, including weights, supplier and lot numbers, balance numbers, solution color, boiling times, and any procedural changes.

What should be done if a student misses a lab class?

They must complete the pre-lab and as much of the post-lab analysis as possible with documentation and instructor approval to receive a passing grade.

What is the primary outcome of the lab exercises?

Lab competency in techniques, attendance, punctuality, teamwork, and tidiness.

How often must a Lab Report be submitted?

Every 2 to 4 weeks after all data has been collected.

What is the policy on late lab reports?

Late lab reports will not be tolerated and are subject to the policy outlined in the syllabus.

What is critical to label in the lab?

Every tube, bottle, flask, cuvette, or other container, especially those with hazardous chemicals or pathogens.

What information must be included on labels for lab containers?

Identity of contents and concentration, initials, date (and time if applicable), class, or a corresponding number/letter with detailed description.

What is the role of lab competency in grading?

It affects your grade based on your ability to perform tasks successfully and use good lab techniques.

What should the format of a Lab Report be like?

It should be easy to read and well organized, including pre-lab, lab experimental notes, results, and analysis.

What is the significance of writing everything down during the lab?

It ensures accurate documentation of the experiment, which is crucial for analysis and understanding.

What is monitored to assess lab competency?

Lab practical exams, workplace evaluations, and placement exams.

What should you do if you make changes to the lab procedure?

Record any changes in the lab handout, even if they were directed by the instructor.

What is the consequence of not attending lab classes?

Missed labs cannot be made up due to the lack of extra time in the semester.

What is the purpose of the lab notebook?

To document all observations, calculations, and procedural details during the lab.

What is emphasized about teamwork in the lab?

Each individual should record their own notes, even when working in teams.

What is the expectation for the quality of work in lab reports?

Students are expected to generate quality work while meeting deadlines.

What is the importance of safety information in the pre-lab write-up?

It ensures that students are aware of potential hazards and how to handle them.

What is the significance of the 21 CFR Part 58, FDA, Dec. in lab practices?

It relates to Good Laboratory Practice (GLP) regulations.

What should be done if a student is unable to submit a lab report on time?

They should refer to the syllabus for the policy on late lab reports.

What does good lab technique encompass beyond skills?

It includes attendance, punctuality, teamwork, and tidiness.

What is the purpose of labeling containers in the lab?

To ensure safe identification and handling of materials, especially hazardous ones.

What became effective in June 1979 regarding laboratory studies?

Standards for the conduct and reporting of nonclinical laboratory studies.

What is the purpose of the standards established in June 1979?

To ensure the quality and integrity of safety data submitted to the FDA.

Why is a laboratory notebook considered a legal document?

Data may need to be explained, defended, reconstructed, or repeated without the original researcher, so it must be understandable to others.

What should be included on the title page of a laboratory notebook?

The title page should be completed when the notebook is issued, and all persons recording in the notebook must sign it and provide an example of their initials.

What is the first component that should be included in each recorded lab?

The objective or purpose of the lab.

What are the required components of a recorded lab?

Objective, plan or outline, step-by-step procedure, raw data, results (including graphs, tables, figures, photos), and conclusion.

What should the conclusion of a lab report include?

Biological and chemical concepts involved, whether the objective was achieved, problems encountered, and suggestions for future experiments.

How should entries in a laboratory notebook typically be written?

As a diary, recording all information about the work as it is done.

What must be done if procedures or information are copied from a source?

The source must be identified in the lab notebook.

When should data entries be recorded during an experiment?

Entries should be made as the experiment proceeds, but no later than when it is done or when an idea is conceived.

What constitutes raw data in a laboratory setting?

Original handwritten information or a printout from equipment.

What is calculated data?

Data derived from a calculation or statistical evaluation of the raw data.

What is transcribed data?

Copied raw or calculated data that should indicate 'exact copy of original' or where the original data is located.

What should be included in the table of contents of a laboratory notebook?

Only the first page number of each multi-page experiment.

What is the significance of documenting research in a laboratory notebook?

It ensures that work is done according to agreed procedures and that data is properly recorded.

What is the role of documentation in laboratory research?

To provide a clear and accurate account of the research process for future reference.

What should be done if a lab experiment involves multiple pages?

Record only the first page number of each multi-page experiment in the table of contents.

What is the importance of including graphs, tables, and figures in lab results?

They help to visually represent the data and findings of the experiment.

What is the recommended practice for recording observations during an experiment?

Observations should be described in detail to ensure clarity and understanding.

What is the purpose of a flow diagram in a laboratory notebook?

To outline the plan or procedure of the lab experiment.

What should be done if an experiment does not go as planned?

Document any problems encountered in the conclusion section of the lab report.

Why is it important for others to understand the lab notebook entries?

So they can replicate the experiment or understand the research conducted.

What is the consequence of not properly recording data in a laboratory notebook?

It may lead to misunderstandings or inability to verify the research findings.

What should be recorded in a lab notebook?

Objectives, ideas, experimental plans, procedures, data, observations, calculations, discussions, conclusions, future plans, unexpected results, deviations from protocols, and all measurements.

What types of measurements should be documented in a lab notebook?

All measurements and important test conditions such as weights, volumes, temperatures, and units (e.g., µl, g, mg).

How should data be recorded in a lab notebook?

Directly into the notebook using black or blue indelible ink, only in the ruled areas of numbered pages, and only one experiment per page.

What is the procedure for attaching forms and printouts to a lab notebook?

Attach only to numbered pages within the ruled area, taped on at least two sides, fully exposed, not covering previous entries, and include the notebook and page number.

When should data be recorded in a lab notebook?

Data should be recorded on the same day it is generated, with dates indicated for events covering more than one day.

What materials and equipment details should be noted in a lab notebook?

Important materials related to reconstructability and repeatability, including specific names, purity, concentration, source, and catalogue numbers.

What equipment details should be recorded in a lab notebook?

Details such as reactors, analytical instruments, hardware, software version numbers, unique equipment IDs, and dates of last maintenance, calibration, and performance checks.

What should be done if mistakes occur in a lab notebook?

Never use white-out, erase, or write over; always record a defensible reason for the correction, circle the reason, and add dated initials.

What is the importance of clarity in data recording?

Data should be legible, clear, and detailed enough for others in the discipline to understand and repeat it, including drawings and defined abbreviations.

What is the difference between fact and opinion in lab conclusions?

A fact is an observable event (e.g., no reaction observed), while an opinion is a subjective interpretation (e.g., these chemicals don't react).