Affiliates

Shibuya Hoppmann Corporation - Elkwood, Virginia
Shibuya Hoppmann operates on the principle of putting the “Customer First”. This concept is embodied in our business by offering customers “turn-key” systems tailored to meet their specific needs. The internal management policies of Shibuya are based on the “Joy of Working,” a philosophy which encourages a positive attitude in our workers allowing them to rise to the challenge of new business opportunities. We will strive to develop new products, and create new markets for our products, by taking advantage of our leading edge technology and drawing on our accumulated years of experience and skills. In this way we will consolidate our business to the benefit of both society and the growth of the company.

Shibuya Kogyo Co., LTD
- Kanazawa, Japan
Validation and project management training for the newly developed validation team, includes GMP audits of Japanese facilities, consulting Japanese clients with FDA procedures and philosophies, master validation plan and protocol writing, overseeing the execution of validation work, GMP facility review, isolation technology assistance, VHP sterilization assistance, training, equipment design and configuration into new technologies.

Associates

Agalloco & Associates [A&A]- Belle Mead, New Jersey
Agalloco & Associates provides a broad range of technical services to the pharmaceutical and biotechnology industries.  Our experience base includes all types of pharmaceutical dosage forms, medical devices, bulk pharmaceutical chemicals and biological products.  A&A has particular expertise in process validation, aseptic processing, isolation technology, sterilization, sterile bulk preparation, process engineering, quality assurance and facility design.  A&A also conducts in-house training for clients focusing on these technical areas.   A&A utilizes a network of highly qualified individuals and organizations for the execution of larger tasks.

 

Rocky Mountain Compliance Specialists, Inc. (RMCS) – Helena, Montana
In business since 1995, Rocky Mountain Compliance Specialists, Inc. (RMCS) is committed to providing science-based technology and innovation derived quality validation services. RMCS is a leading industry source for validation consulting and contract services. We offer a full range of services to FDA regulated companies seeking support in validating manufacturing processes and systems. Our specialties include cleaning and sterilization validation in addition to other aspects associated with companies that are expanding or require complete facility start up manufacturing process support.

 

The Williamsburg Group, LLC – Gaithersburg, Maryland
The Williamsburg Group specializes in consulting services related to CGMP compliance and auditing, quality systems, design review, aseptic processing and sterilization technology, sterile filtration, due diligence evaluation, process validation, regulatory liaison and general technical services.

AKA & Shibuya

Akers Kennedy and Associates has enjoyed a long and fruitful collaboration with Shibuya Kogyo Co. LTD. of which we are extremely proud.  Since our affiliation with Shibuya began in 1991, we have been honored to participate in the introduction of validation services in Japan, and in the advancement of the science, engineering and art of sterile product manufacturing globally.  Shibuya introduced isolator technology for aseptic processing in Japan and has done more than any other equipment manufacturing company to implement advanced process control and automation in aseptic processing.  In 1994 we collaborated with Shibuya on the largest isolator technology project ever undertaken and since that time we have been fortunate enough to have participated in the PAsepT project to bring advanced and direct process control concepts to aseptic processing, in the development of HYDEC the most efficient vapor phase Hydrogen peroxide decontamination system in the world, in the use of robots for manufacturing and product testing and other advancements. We know that we will continue to be inspired by Shibuya’s commitment to quality, innovative spirit, unparalleled engineering excellence and scientific capabilities for years to dome.  Together Shibuya Kogyo Co. LTD and Akers Kennedy and Associates are focused upon ushering in the future of aseptic processing. 

The equipment photos running on the banner are of Shibuya equipment.  Please click on the links to Shibuya Kogyo Co., Ltd. and Shibuya Hoppmann Corporation for detailed information about these outstanding products.