KV

Isotonicity

  • Definition: Isotonicity refers to the state of having the same osmotic pressure as another solution, often involving comparisons with hypertonic (higher osmotic pressure) and hypotonic (lower osmotic pressure) solutions.
  • Relevance to blood: The isotonic solution is crucial in relation to the bloodstream, with a standard concentration of about 0.9% salt.

Conductivity

  • Importance: Conductivity is important because excessive salt ions in a solution can lead to product instability.

Assay Testing

  • Definition: Assay testing is a method to measure the amount of a particular substance within a product.
  • Purpose: Primarily ensures that the yield of the product is as expected.

Quality Control (QC) Microbiology

  • Responsibilities: QC microbiology ensures that the environment, personnel, and products are sterile and clean.
  • Processes: Includes monitoring and evaluating production environments and conducted sterility tests.
  • Stability Testing: This aspect combines efforts from QC chemistry and microbiology to test finished products already available on the market or assess new products during development.
  • Shelf Testing: Products stored for extended periods (e.g., three years) may undergo monthly testing to maintain sterility and stability.

Equipment Used in Testing

  • pH Meters: Used for calibrating various pH levels, generally using solutions of pH 2, 4, 7, and 10 for daily calibration to confirm accurate operation.
  • Process Testing: Involves sampling during product formulation to ensure specifications are met, with adjustments made using bases or acids as needed.
  • Dilution and Titration: Methods employed to adjust pH in samples using calculated multipliers.
  • Conductivity Testing: Ensures metal tanks storing the products do not interfere with the stability of the product by reacting with salt ions.

Laboratory Techniques

  • Mass Spectrometry (Mass Spec) and Infrared (IR) Testing: Utilized for identifying various substances, determining the safety of the active pharmaceutical ingredient (API) by checking for impurities.
  • Microbiology Methods: Involves using various identification methods, including manual gram staining and automated plate recognition for environmental safety compliance.
    • Gram Staining: Differentiates bacterial species based on cell wall characteristics; purple = gram-positive, and red = gram-negative.
    • Aerobic vs. Anaerobic Testing: Determines the oxygen requirements of microbial species.

Media Plates Used

  • Tryptic Soy Agar (TSA): A general media used to culture nearly all species; if further investigation is needed, samples may be transferred to specialized plates like SDA for fungal species.

Air Sampling Techniques

  • Inline and Portable Samplers:
    • Purpose: To collect samples from the air for environmental monitoring to assess the presence of airborne contaminants.
    • Process: Media plates are exposed for a vacuum cycle, resulting in a waffle pattern that indicates bacterial growth.

Colony Counting

  • Electronic Colony Counter: Devices that can visually identify and count colonies on media plates, supplemented with manual counting methods on graph-like rulers for interpreting results in CFUs (Colony Forming Units).

Laminar Flow Hood

  • Definition: A device that provides a precise stream of clean air to prevent contamination during microbiological work.
  • Types: Commonly horizontal or vertical designs that push clean air either downwards or outwards.
  • Smoke Studies: Used to validate clean airflow; if smoke shows turbulent airflow, it indicates issues with the system which could introduce contaminants into the product.

Manufacturing Environment

  • ISO Standards: Areas where products contact vials must meet specific purity standards; e.g., ISO 5 environments are mandatory for sterile conditions.

Leachable Testing

  • Importance: Essential for ensuring that no toxic substances leach into injectable products, such as adhesives or container materials contaminating the product over time.
  • Current Developments: New lab dedicated to leachable testing valued at $17 million is being established for thorough in-house analysis.

Internship Opportunities

  • Internship Structure: Programs designed for students, primarily targeted at juniors, where each department has specific projects for interns throughout the summer.
  • Paid Positions: Internships are compensated, which is a distinguishing feature compared to unpaid intern models.
  • Duration: Typically from May to August, though flexible with end dates due to academic obligations.
  • Application Process: Applications will open at the start of the spring semester with a structured interview process after evaluations.

Intern Responsibilities and Learning Outcomes

  • Departmental Variations: Responsibilities vary based on the department, with each intern presenting their project outcomes to the executive team by the internship's conclusion.
  • Skills Focus: Emphasis on gaining deeper understanding and exposure to industry challenges and expertise within students' field of study.