The Akers–Agalloco Method - Pharmaceutical Technology

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The Akers–Agalloco Method


Pharmaceutical Technology
Volume 29, Issue 11

The risk to contamination associated with personnel is such that the contributions for these factors must be weighted more heavily than those derived from the contributing factors that are not human-related. An extra weighting of 10 has been assigned to those process steps in which personnel presence and close interaction with sterilized products, materials, and equipment is mandated: aseptic compounding, aseptic setup, and aseptic filling.

The risk for the overall process is the sum of the contributions from all of the relevant process factors, weighted according to the effects of various practices. Determination of the individual factors varies and includes simple multiplications that reflect the combined influence of variables within an individual process step. Weighting factors are included in the lyophilization and aseptic filling parameters to provide a more balanced consideration of these process steps. Addition is used as the primary means of calculation for the following reasons:

  • It substantially simplifies the calculations once the individual contributions have been determined.
  • It is consistent with the sense that adding an activity (e.g., lyophilization) to a process adds risk to that process (e.g., solution filling). This allows the elements of a larger activity to be addressed individually and directly and optimized from a risk perspective more easily.

As in the other risk-assessment models, a low score in the present model suggests a low potential for contamination. The risk contributions for the various process elements of the overall aseptic process are described below and quantified in the tables that accompany this text.

The risk assessment relies heavily on the environmental technology used in the aseptic process. The authors have applied a corrective factor that is based on the individual contributions of the various process steps to the final score. If aseptic compounding and aseptic filling are not performed using the same environmental technology, then the contribution risks for each should be calculated separately, on the basis of the technology used.

Facility contributions


Table IIa: Facility considerations for cleanrooms.
Facility contributions depend on the types of environments provided for the supporting tasks associated with aseptic processing, including sterilization unloading and personnel gowning, and the background environment for the fill zone. Additional contributions from the facility derive from the sanitization method used and the frequency of treatment (see Table IIa).

Similar parameters relate to using isolators, but the factors and weighting are adjusted to suit the differences in technology (see Table IIb). The authors have included RABS within the cleanroom category because this is the technology that it most resembles. The model for facility contributions can be expressed as:

cleanroom contribution = sanitization interval factor sanitization process factor background classification factor

or:

isolator contribution = decontamination interval factor decontamination factor background classification factor


Table IIb: Facility considerations for isolators.
The intervals between sanitization and the type of process applied are multiplied and added to the contribution from the background environments. Smaller facilities where one room serves multiple purposes (e.g., filling and unloading) receive a lower score because of their simplicity.


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