Solutions
SMOKE STUDIES IN CLEAN ROOMS, HOODS, & ISOLATORS
Utilizing smoke studies in clean rooms, hoods, and isolators reduces risk of compliance issues, decreases downtime, and improves overall efficiency.
Our smoke studies employ state-of-the-art smoke-generating technology to ensure accuracy and precision. We use high-definition video recording to document the entire process, providing clients with detailed visual evidence to support regulatory inspections and internal audits.
We understand that each pharmaceutical facility is unique.
Our team works closely with clients to develop customized smoke study plans that align with their specific operational needs and regulatory requirements. This tailored approach ensures that our clients receive the most relevant and effective solutions. Our experts offers a comprehensive package that addresses both the specific needs of smoke studies in clean rooms and the broader requirements of facility commissioning and engineering. Our team uses advanced smoke-generating technology to assess airflow, ensuring compliance with FDA and ISO standards, create comprehensive reports and video documentation to support regulatory inspections and internal audits, and detect and address areas of turbulence or improper airflow to minimize contamination risks.
Verista's Smoke Study Offerings
Smoke studies are crucial for the initial validation and routine requalification of cleanrooms. They help ensure that cleanrooms maintain the required cleanliness levels by verifying that airflow patterns effectively remove contaminants and prevent cross-contamination between areas.
Laminar Flow Hood Testing
Laminar flow hoods, used for aseptic processing and product protection, rely on unidirectional airflow to maintain a sterile environment. Smoke studies verify that these hoods provide consistent, laminar airflow, ensuring the protection of products and processes from contamination.
HVAC System Verification
In pharmaceutical manufacturing, HVAC systems must control temperature, humidity, and particulate levels. Smoke studies verify that these systems provide appropriate air exchanges and pressure differentials, maintaining the integrity of controlled environments.
FACILITY DESIGN & OPTIMIZATIon
During the design phase of new pharmaceutical facilities or the renovation of existing ones, smoke studies in clean rooms help optimize the layout of airflow systems. They provide insights into how air moves through spaces, guiding the placement of equipment and the design of air handling systems to minimize contamination risks.
REGULATORY COMPLIANCE
Compliance with regulatory standards, such as those set by the FDA, EMA, and other international bodies, requires thorough validation of environmental controls. Smoke studies are a key component of this validation, demonstrating that the facility can consistently maintain the required conditions for pharmaceutical production.
troubleshooting & Maintenance
Smoke studies in clean rooms are used for ongoing maintenance and troubleshooting of existing facilities. They help identify and correct issues with airflow that could compromise product quality or process integrity, ensuring continuous compliance with regulatory standards.
Bundle services for a cost-effective solution that meets a range of needs.
Verista is unique in that we offer a comprehensive suite of services. This integrated approach allows us to address not only the immediate needs of smoke studies in clean rooms, but also the broader requirements such as commissioning, project management, and engineering consulting.
Quality Management & Auditing
The successful delivery and confirmation of industrial and regulatory accepted quality systems for Pharmaceuticals, Biotech’s, Medical Device providers, and Clinical Support organizations requires resources, processes and technologies. Our consultants are experts in the development, enhancement and roll-out of client Quality Management Systems (QMS) including the associated policies and procedures, and audit expertise to support our clients internal and external auditing requirements.
We support clients internal auditing and gap analysis efforts with expertise in risk-based applicability against a defined QMS.
We support client inspection readiness preparation, hosting and post-inspection consultation / issue resolution. Our team has experience reviewing observations and constructing/implementing plans for regulator response and remediation.
We support client design, execution, reporting and follow-up of external (vendor audits).
Verista's Smoke Study Offerings
Infrastructure, Cybersecurity & Digital Transformation
The control and management of a company’s infrastructure ensures that the backbone of all applications is maintained consistently and in a controlled manner – it is the foundation for all business applications. Our experts ensure that security and service management are built into all application environments.
We develop the policies and procedures necessary for the management of Infrastructure.
We develop specific requirements, design and testing to ensure that an environment functions as intended.
We develop the processes to define configuration items and the management of their changes.
We provide guidance and development on best practices on aligning IT Services with the needs of your regulated applications.
Our cybersecurity experts can provide guidance on the NIST Core Framework functions to identify, protect, detect, respond and recover in a secure environment, including risk management, data security, monitoring, mitigation and recovery planning.
Our digital transformation experts can improve your process/labor efficiency and overall cost position through implementation of electronic tools /applications. Our team can work closely with your process experts on a custom digitized solution, or can offer one of our standard solutions refined in-house.
