Case Study - CLEANING VERIFICATION - Hyde Engineering + Consulting For Medicines Manufacturing

Cleaning Verification and Validation

Site Gap Evaluation

Cancer Therapies

Project

Description

Hyde performed a thorough gap analysis of the Cleaning Program for a drug product in short supply that was being manufactured at a contract manufacturing facility under consent decree.

Hyde's work on the project involved Analytical Laboratory studies, cleaning verification program development and execution as well as cycle development and operational qualification.

Scope

and Deliverables

Cleaning

Verification

URS REQ #	DESCRIPTION	QRA	FAT	SAT	IQ	OQ	PQ
OPERATIONAL REQUIREMENTS
2.1	Capacity
1	CSG used for NL to 8 Bar clean steam pressure distribution	NCOP			CPP	CPP
2	Supply Clean Steam to Autoclave	CPP			CPP	CPP
2.2	Process Requirements
1	Clean Steam when condensed must meet EU purity requirements	COP			TEST	TEST
9	Clean Steam condensation point	COP			TEST	TEST
13	Clean Steam - Phases	CPP
2.3	Process Control
1	Automated Unattended Operation	NCOP	TEST	TEST
2	CSG will be controlled and monitored	NCOP
3	Shutdown and Alarm tested on Remote	NCOP
2.4	Cleaning
1	Equipment and piping will be cleaned after FAT	CPP
2	All surfaces cleaned by products to be SS 15-20 EP finish	NCOP			TEST	DOC