Pilot batch size for non-solid

GOOD VALIDATION PRACTICE (cGVP)
1

Dear Colleague,

As we all know the rule of 10% or 100,000units is applied for pilot batch, whichever is higher. This is well understood for solid dose. I’m seeking an advise from the forum, for the minimum pilot batch size for non-solid. E.g.:

  • Nasal spray
  • Liquid/Cream
  • Sterile powder
  • Sterile Liquid
  • Biotech

Please help.

Thanks in advance,
MBM

2

I can tell you about sterile and Biotech Products.

Sterile liquids normally 2 to 10 liters of batch is considered Pilot for normal molecules (10000 units)

For Dry powder Injections it is about 2kgs depending up on bulk density.(2000 units)

Biotech products are also known as clinical trial materials. They are very expensive. You may consider a batch from 100 to 300 vials per batch.
The antibody formualations are of larger interest now as these formualtions are more viscous in nature. To understand their filling charecterestics one should carry more batches.

Biotech products do have a problem of foaming due to virbations in the manufacturing lines. Due to this reason a late pilot batch is taken and it is considered for stability too.

Biotech products are in form of Ointments like growth factors, Lyophilized forms, Liquid forms, Viscous liquids (Anti body formulations), Pegylated forms and even in Prefilled syringes. Its rather difficult to tell exactly what will be the pilot batch. The main reasons are expensive materials, Secrets involved in companies and change of formulation strategies to excel in sales of products.

Regards