Monitoring for OSHA compliance for exposure to gasses/organics utilizing spectrometry for real time monitoring and results. Gasses include formaldehyde, xylene, ETO.
Laminar Flow Clean Benches
In-line HEPA Systems
HEPA Filter Supply/Exhaust Housings
Other HEPA Filter Devices
ATC utilizes CETA™ registered cleanroom certification professionals
ANSI Z 9.5
Other standards may also apply.
Biological safety cabinets [BSCs] are certified to meet NSF-49, OSHA, NIH/CDC, and the manufacturer’s specifications.
Our focus at Advanced Testing and Certification is testing and certifying controlled environments.
ATC utilizes state of the art equipment for testing and employs highly trained certified test engineers. ATC’s goal is to ensure quality in every job we do by utilizing current Good Manufacturing Practices (GMP) in all of our testing and documentation.
“Good Manufacturing Practices” or “GMP” are guidance that outline the aspects of production and testing that can impact the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it passes all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing guidelines. Therefore, complying with GMP is a mandatory aspect of pharmaceutical manufacturing.
ATC utilizes NSF® certified technicians for testing biological safety cabinets.
ATC offers comprehensive testing, certification, and repair of biological safety cabinets. Our skilled technicians are authorized to perform warranty repairs for all major equipment manufacturers. All testing is performed in accordance with established ATC standard operating procedures [SOPs], which are updated to remain compliant with federal and international safety guidelines, current good manufacturing practices [cGMPs], and quality assurance systems.
Biological safety cabinets [BSCs] are certified to meet NSF-49, OSHA, NIH/CDC, and the manufacturer’s specifications.Primary Tests:
Although there are a number of them, all guidelines follow a few basic principles: Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices) Operators are trained to carry out and document procedures. Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented. Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. The distribution of the drugs minimizes any risk to their quality. A system is available for recalling any batch of drug from sale or supply. Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the company’s responsibility to determine the most effective and efficient quality process.
A JCAHO inspector who spent 7 hours inspecting our inpatient pharmacy spent a lot of time carefully looking over all the pharmacy certification reports. At the end of the day, he said the presentation and format of Advanced Testing and Certification's reports were the best he had seen in his whole career.
Kendrick Sue-Ako, CBETTripler Army Medical Center, Hawaii USA
You guys are great! Not just good but GREAT!
Joe Rodgers | Bio - Med Service ManagerSonora Quest Laboratories
You have been wonderful to us!
Hanna Wooldridge, CPhT | Lead Pharmacy TechnicianIronwood Cancer and Research Centers
These national and international associations are a cornerstone of our leadership in the industry. These organizations provide certification and continuing education for employees. They promote quality assurance for existing standards while facilitating new methodologies. It is also how we foster collaboration with government and regulatory agencies on issues affecting the controlled environment and contamination control industries.