Reply please i’m waiting
- Environmental conditions (Temp., RH & DP) should be as per checklist & SOP
- Area should be cleaned, labelled and meet sanitation program me.
- Previous batch documents, labels and material should not be available
- All equipment and area log should be updated.
- equipment should be cleaned and labelled as per requirement of SOP.
6.Equipments calibration should be within its due date shall be verified
7.Area walls should be free from cracks and joints
8.Equipments parts performance ( like punches if any damage ) also shall be verified
Thank for info. About lIne clearance
9- Check Balance daily and monthly verification and calibration updated with lable.
10-Equipment Preventive maintenance and Qualification Lable updated.
11-Dust bin empty
12-All equipment or instruments calibration tags with in validity period.
It is always preferred to have an exhustive checklist of Line clearance certification. This activity should be divided in to two major parts, “Packaging Line clearance” for packing operations and “Area Clearance” for Manufacturing operations.
Separate checklists should be developed and implemented for each type of Line clearance activity and should be part of QA SOP. Line clearance certification should be documented in BMR & BPR.
Line clearance is a process which provides a high degree of confidence or assurance that the said line or area is free from any unwanted residue or left over of previous processing’s before proceeding for next process. Quality assurance has to provide / certify Line clearance before the start of any activity whether it is batch to batch change over and Product to product change over.
Criteria of Batch to batch change over ,
Change over from one batch to another batch of same product and same Strength or increasing in strength provided the excipients is same.
Cleaning between batches of same product but in ascending or increasing strength.
Criteria of Product to Product change over ,
- Change over from one product to another product.
- Change over form one product to same product with descending or decreasing strength.
- Change over between batches / product with different colour/ Flavour / Excipients.
- Change over after post maintenance or when the next product is not known (as applicable).
- Continuously running of one batch for a longer period of time.
- Area or Equipment is kept ideal for more period of time.
Line clearance should be carried out at change over by Manufacturing, Packaging, Raw Material Store, Packing Material Store etc independently for the stages where final dosage form & intermediates are formed, handled and processed.
3 main components called 3C
Sir jaise mere product filling se khtm hua h
Ceftriaxone + sulbactam
Iske baad chlna h
To kya cleaning procedure rhega or pura process btaiye sir app
Kitne time baad hm batch le skte h filling m
yes u willhave to perform complete cleaning
This is a product change. Hence please follow your SOP of product change over cleaning. All filling equipment must be cleaned as per product change over SOP. And ensure cleaning is adequate. (sending swab or rinse samples to QC for analysis as per your SOP and wait for the results). Then seek line clearance from QA as I have explained in y previous communications here. Only after satisfactory line clearance certifications by QA you can start filling of next product.