Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Cleaning Validation of Paracetamol Tablets as a Dosage Formulation


Affiliations
1 Department of Quality Assurance Technique, Padmashree Dr. Vithalrao Vikhe Patil College of Pharmacy, Ahmednagar, Maharashtra. 414111, India
     

   Subscribe/Renew Journal


Cross contamination is one of the major problems focused in manufacturing of drugs utilizing common facility which leads to inferior quality of final product and cause considerable loss to the company. Contamination of one batch product with significant levels of residual active ingredients from a previous batch and contamination by microorganisms are the real concern. Cleaning and decontamination is one of the major and critical activity in pharmaceutical operations. The concept of purity and safety are directly related to the cleaning operations. Cleaning programmers are necessary simply to prevent our manufactured products from being contaminated. These are cross-contamination of one product into another , product contamination by a foreign material and microbial contamination The cleaning validation is a documented process that proves the effectiveness and consistency cleaning of pharmaceutical equipments to meet the regulatory requirements. Manufacturing of paracetamol and other tablets utilizing common facility, where paracetamol could be a possible cross contaminant. Hence the present study was carried out to validate the cleaning activity from both regulatory and quality prospective. Visual inspection, Swab sampling for chemical residue and for microbiological analysis were carried out to validate cleaning activity and results from all methods were complying with acceptance criteria.

Keywords

Paracetamol, Sodium Lauryl Sulphate, Cross Contamination, Cleaning Validation.
Subscription Login to verify subscription
User
Notifications
Font Size


Abstract Views: 261

PDF Views: 0




  • Cleaning Validation of Paracetamol Tablets as a Dosage Formulation

Abstract Views: 261  |  PDF Views: 0

Authors

S. A. Hapse
Department of Quality Assurance Technique, Padmashree Dr. Vithalrao Vikhe Patil College of Pharmacy, Ahmednagar, Maharashtra. 414111, India
B. V. Bhagat
Department of Quality Assurance Technique, Padmashree Dr. Vithalrao Vikhe Patil College of Pharmacy, Ahmednagar, Maharashtra. 414111, India
V. S. Wagh
Department of Quality Assurance Technique, Padmashree Dr. Vithalrao Vikhe Patil College of Pharmacy, Ahmednagar, Maharashtra. 414111, India
P. T. Kadaskar
Department of Quality Assurance Technique, Padmashree Dr. Vithalrao Vikhe Patil College of Pharmacy, Ahmednagar, Maharashtra. 414111, India

Abstract


Cross contamination is one of the major problems focused in manufacturing of drugs utilizing common facility which leads to inferior quality of final product and cause considerable loss to the company. Contamination of one batch product with significant levels of residual active ingredients from a previous batch and contamination by microorganisms are the real concern. Cleaning and decontamination is one of the major and critical activity in pharmaceutical operations. The concept of purity and safety are directly related to the cleaning operations. Cleaning programmers are necessary simply to prevent our manufactured products from being contaminated. These are cross-contamination of one product into another , product contamination by a foreign material and microbial contamination The cleaning validation is a documented process that proves the effectiveness and consistency cleaning of pharmaceutical equipments to meet the regulatory requirements. Manufacturing of paracetamol and other tablets utilizing common facility, where paracetamol could be a possible cross contaminant. Hence the present study was carried out to validate the cleaning activity from both regulatory and quality prospective. Visual inspection, Swab sampling for chemical residue and for microbiological analysis were carried out to validate cleaning activity and results from all methods were complying with acceptance criteria.

Keywords


Paracetamol, Sodium Lauryl Sulphate, Cross Contamination, Cleaning Validation.