Tag Archives: MHRA

ORAL SOLID DOSE – Architectural Considerations

Hello good people of the world! Today we’re talking about architectural considerations in the design of oral solid dose (OSD) manufacturing facilities.

In addition to normal architectural standards, the following must be considered for OSD manufacturing facilities:

  • Manufacturing process flow
  • Personnel flow
  • Equipment flow (clean and dirty)
  • Waste flow

Risks to consider when mapping flows include:

  • Risk of contamination from outside contaminates
  • Risk of cross-contamination
  • Risk of mix-up

Risk mitigations should consider:

  • Process containment
  • Isolators
  • Environmental controls
  • Room size
  • Transition spaces and airlocks
  • Personnel controls such as gowning
  • Administrative controls such as frequency of operation

Like this MWV (Mike Williamson Validation) blog post? Be sure to like, share, and subscribe!

Oral Solid Dose – Isolation and Containment

Hello good people of the world! Today we’re going to talk about isolation and containment considerations in oral solid dose manufacturing. The purpose of isolation and containment is to control the level of pharmaceutical ingredient exposure to personnel and the environment. It is typically not possible to eliminate all exposures, so we try to reduce it to a tolerable level, which must be defined.

The CFRs and other regulations require manufacturers to limit exposure to customers of any undesirable substance. Limits have been established by industry group and regulatory bodies, and quantify things such as Allowable Daily Exposure (ADE).

Things to look at when considering isolation and containment include:

  • Material flow
  • Personnel flow
  • Operator interventions
  • Sampling
  • Waste flow
  • Maintenance procedures
  • Utility interactions

Isolation and containment risks must be evaluated and mitigated to get a solid handle on the implications. A multi-disciplinary approach must be used. Migations may include:

  • Physical barriers
  • Air control
  • Cleaning procedures
  • Disposables
  • Training

What considerations come in to play in your isolation/containment strageties? Comment below!

Like this MWV (Mike Williamson Validation) blog post? Be sure to like, share, and subscribe!

ORAL SOLID DOSE – Supporting Equipment and Systems

Hello good people of the world! Continuing the series on oral solid dosage forms, today we’re going to talk about supporting equipment and systems. The main equipment in unit operations get the spotlight when it comes to manufacturing Oral Solid Dosage forms, but they cannot work without supporting equipment and systems.

Supporting Equipment:
Typical supporting equipment in a OSD manufacturing process includes:

  1. Air Systems: all modern manufacturing processes use air systems for process, instruments, and environment. HVAC helps control environmental conditions, including particulate (viable and nonviable) counts, temperature, and humidity. Compressed air systems may be used in the process to cool or cover product, such as with nitrogen, or operate unit operation steps, such as in fluid bed drying. Automated systems will use compressed air to pneumatically control valves and other components.
  2. Dust Collection: compared to biotech and other pharmacuetical processes, OSD processes have the added complication of dust collection. OSD material movement and processes can create a lot of dust, which can be a risk from a product quality point-of-view, but also a safety point-of-view, since dust can lead to fires and even explosions. Dust collection equipment must be employed to minimize and control dust.
  3. Vacuum Systems: vacuum systems may be used for cleaning, dust collection, and also in process steps such as vacuum drying.

Supporting Systems:
Typical supporting systems include:

  1. Change Control: it is expected that engineering changes are controlled with quality oversight through a formal process.
  2. Preventive Maintenance: it is expected that regular preventive maintenance be performed and documented formally.
  3. Calibration: it is expected that “critical” instruments are calibrated at regular intervals traceable to an international standard. Calibration procedures and results must be formally documented. The method to determine and results of the determination of critical instruments must be documented.

What supporting equipment and/or systems do you use in your OSD manufacturing process? Comment below!

Like this MWV (Mike Williamson Validation) blog post? Be sure to like, share, and subscribe!