Tests for holding time study at different Manufacturing Stages in Pharma

   Examples of stages and tests that may be considered for hold time study based on risk  assessment and specific product needs:

Stage	Examples of tests to be considered
Dispensed materials storage Microbial test	Microbial test
Solutions prepared (including granulating pastes, coating solutions and coating suspensions)	Physical appearance Specific gravity Viscosity Sedimentation pH Microbial test
Granules	Description Assay Loss on drying Water content Particle size distribution Bulk density Tap density Angle of repose
Blend	Microbial test Moisture content Blend uniformity Particle size Bulk/tapped density
Core tablets – uncoated (In bulk containers)	Description Hardness Thickness Friability Appearance Dissolution Disintegration Assay Degradation products/related substances (where applicable) Uniformity of dosage Units Microbial test
Coated tablets (in bulk containers)	Description Hardness Thickness Friability Appearance Dissolution/dissolution profile Disintegration Assay Degradation products/related substances (where applicable) Uniformity of dosage units Moisture content Microbial test

Cleaned equipment holding time study

-CEHT mean Cleaned equipment holding time study.

-Cleaned hold time is defined as the time period after cleaning of the equipment; can be used. 

-We can also say that time between the completion of cleaning and the initiation of the production activity.     

      

-The clean equipment cannot be remain clean for infinite time. There may be the chance of contamination and microbial growth.

-If the equipment is stored wet condition, there may be the chance of the growth of the microbial growth. 

-what the longest time interval might be that the equipment would be unused after cleaning. 

-Purpose of the study of cleaned equipment holding time study is to establish holding time for cleaned equipments by studying Microbial load.

-After performing the cleaned equipment holding time study it need to be document

Cleaned Holding time study protocol should have following details:

1.    Purpose of the study

2.    Scope

3.    Responsibility

4.    Details of equipment

5.    Sampling plan

6.    Sampling and analysis procedure

7.    Acceptance criteria

8.    Report preparation and evaluation of results

9.    Conclusion

Protocol of Dirty equipment holding time study

Protocol equipment holding time study have following content:

1.Purpose

2.Scope

3.Responsibilities

4.Details of Equipment

5.Sampling plan

6.Sampling and analysis procedure

7.Acceptance criteria

8.Report preparation and evaluation of results

9.Conclusion

Purpose:

Purpose of the study of dirty equipment holding time study and this protocol is to establish holding time of dirty equipments by studying Microbial load and cleaning of the equipment after holding for specified period till next batch or next product is manufactured by using same equipment.

Scope:

This protocol is applicable to for the all dirty equipment which used to manufacturing of active pharmaceutical ingredient.

Responsibilities:

Quality assurance:  To prepare and review the protocol.

                            To execute the protocol and coordinate for the activity    perform during the  execution of the protocol

QC/Microbiology:    To collect the sample from the equipment

                                  To analyse of sample.

Production:              To support the other department to complete the all activities.

Details of Equipment:

The details of the equipment in which the dirty equipment holding time study is going to performed.

Sampling plan:

How many days or hour study going to performed, Frequency of the dirty holding time study. It depend on the time period the dirty equipment need to be hold.

Sampling and analysis procedure:

The procedure which follow  for the dirty equipment holding time study.

It include

1.    Microbial analysis

To check presence the any microbial growth into the equipment.

2.    Chemical Analysis:

To check the impurity profile if there is any change  

To check the presence of any residue after cleaning

Acceptance criteria:

As per available specification.

Report preparation and evaluation of results:

To compile all the results and compilation in sheet and on evaluation of the result from results

Conclusion:

According to result conclusion how many days/hour you can keep  equipment in uncleaned

Related Post:

CleanEquipment holding time study