Project Proposal in Gulf Countries

Consultation on the designing the Manufacturing Facility based on current guidelines floor plan and lay out in compliance with ISO 13485 and FDA and Gulf council visit team

• Advice and proposal of the floor plan
• Advice and proposal of clean rooms design, clean room validation recommendations, clean room SOP and work procedures to prevent contamination, clean room particle, clean room gowning and dress code

Machines and Equipment for manual, semi-automated and automated for small scale and large scale manufacturing

• Advice and proposal of key manufacturing equipment’s for small scale, medium scale and bulk scale and suppliers and expect cost. Production plan to manufacture plates ranging from 2,000 to 50,000 plates per day
• Price negotiation of equipment and recommendations

Outsourcing Raw Materials, bulk price,

• In GULF MARKET there are 40 products that are fast moving and 40 to 45 medium to slow moving products that require Raw material from different source with bulk price, 40 % culture media contain sheep blood and these products need special raw material and special formulation to prevent discoloration during transport and storage
• Selection and recommendation of DCM (Dehydrated Culture Media) from different known suppliers with excellent bulk price where you can save from the list price
• Selection and recommendation of supplements from different known suppliers. Supplements from many companies will fail and proper selection of supplements are critical for the products to pass in the QC driven GULF MARKET. In house preparation of supplements which can cut cost of production.
• Contact and negotiate best raw material bulk prices. For instance the raw material that is sold for 300 to 400 Dirham - Saudi riyal in local market for 500 grams can be reduced for less than 75 Dirham - Saudi riyal by bulk price
• Manufacturing biphasic blood culture bottles which are mostly used in laboratories without automation. Outsource the bottles for very good landing price
• Establish Chromogenic culture media business which has a good market
• Production, Quality control, Packaging of Viral transport Media and Molecular Transport media

Petridish, glass wares, blood bags, Printing & Packaging Components

• Identify and negotiate suppliers of good packaging components (Petri dishes, bottles, borosilicate glass tubes etc). All these products can be obtained bulk price there by reducing the production cost and increasing the profit and better compete in the GULF MARKET
• Negotiate best prices for packaging components and printing solutions
• Manual as well as fully automated packaging machine solutions

Batch Manufacturing Records, in -process control and traceability and recall documents

• Batch Manufacturing records for selected range of products needs to be prepared before the start of manufacturing, and then modify them depending on the supplier of raw materials and supplements and different formulations are standardized based on GULF MARKET customer need.
• Batch file and other documents for traceability

QC and QA Testing Methods

Quality control testing methods needs to be preparing for every product before the start of manufacturing. These are routine tests required before the products are released to market. QC and production instruments, ATCC culture collections handling, processing and QC

Site Master File

This is a document that is required by most of certifying agencies (organizations) and auditors. It is an overview of the company to prepare the company for GULF MARKET team visit, FDA visit and other tender committee factory visit and to obtain ISO 13485. The file will be done by licensed ISO consultants and all supporting documents will be done by our team

Validation and calibration Master Plan

This document describes the company validation policy for facility, equipment, systems, software etc. Validation and calibration guidelines to get it done by a notified third party in GULF COUNTRIES. Advice on the temperature mapping of cold storage and trucks

Product Catalogue, brochures and website designing

Recommendations and edition, IFU, product flyers

Standard Operating Procedures (SOP) from raw material receiving to delivery in compliance with ISO and SFDA

Depending on the requirement of GULF COUNTRIES regulatory authorities draft protocol will be prepared for ISO 13485 medical device certification. Third party service will be required for accreditation preparation and implementation. Main documents will be prepared by the notified / authorized body and all supporting documents will be prepared by us. Necessary SOP and work instructions will be prepared by us

Selecting and appointing logistics in compliance with FDA

Consultation on Sheep Blood harvesting farm (Setting up the sheep farm, providing necessary sheep blood collection instrument for reasonable price, training the staff for bulk sheep blood collection, pooling and processing the blood for production)

Animal blood is one of the most frequently used culture media ingredient. Due to its short shelf life import can be difficult. Considering 40% culture media contains sheep blood it is worth investing in this project.

• Arrangements to set up farm or contract this service with local farms
• If own farm is considered, animal welfare, selection of the right breed, selection of the correct feed should be in place
• Selection and custom made blood collecting accessories should be ordered & purchased
• Blood collecting and blood pooling bags needs to be outsourced & purchased
• Blood collecting set needs to be purchased
• Staff training should be provided – how to select the right sheep by age, sex, weight, how to collect and how to process blood
• Small scale / mobile laboratory needs to be set up
• Standard Operation procedure and other documents needs to be originated
• Logistic for Storage and transportation should be arranged