YOU WON'T HEAR "THAT'S IMPOSSIBLE" FROM US COMPLETE PROCESSES FROM ONE SOURCE We are specializing in the assembly of complex medical products, are able to adjust to the individual requirements of our customers and to offer competitive prices.
Especially if the parts of the product have to be cleaned, it is reasonable to put the entire production in our hands.
If desired, we can also take over the procurement, disposition and storage of components. inpac's wide net of suppliers comprises companies experienced in the medical device sector like injection molders and metal surface refiners. We ensure a hygienically proper course and avoid interface problems as well as unnecessary transports.
Prior to producing a product, our employees undergo a comprehensive training. Our knowledge in development, production and quality assurance guarantee even the assembly of complex products at highest quality standards.
YOUR SAFETY IS RELEVANT FOR US CLEANING METHODS THAT PERFECTLY SUIT YOUR DEMANDS cleaning disinfection ultrasonic cleaning plasma cleaning cleaning validation
Medical products must have and keep a defined cleaning condition. The aim of the cleaning is the depletion of the bioburden, of the particulate and chemical load. Therefore, our experts develop individualized cleaning strategies together with the customer. We analyze pre-processes with regard to potential contaminations. According to the product features, cleaning methods are developed that meet the normative and legal requirements to a medical product. We have many years of experience in the areas microbiology, material properties, and production processes – and, thus, can offer optimum support to our customers.
SENT TO THE CUSTOMER IN ASEPTICAL PACKAGES STANDARDIZED METHODS FOR YOUR PRODUCTS radiation (beta and gamma) gas (ethylene oxide) steam collaboration with certified sterilization companies planning and implementation of the validations sterilization certificates of the batches surveyed by independent accredited laboratories In collaboration with certified sterilization companies, each product is sterilized according to validated methods. The processes are implemented in accordance with the international standards ISO 11137 (sterilization with radiation) and ISO 11135 (sterilization with gas). We document the validation and prepare a sterilization certificate for each individual batch. The vali- dation of production processes and the materials used always relate to the specific product of our customers. As a basic principle, all production means used by us are qualified.
WE VALIDATE ALL PROCESS SEQUENCES PACKAGING, CLEANING, STERILIZATION, TRANSPORT, AND DURABILITY cleaning validation sterilization validation packaging validation accelerated / real-time aging simulation of transport accredited laboratories
A medical product – safely produced and sterile: To achieve this, all processes from cleaning via packaging up to sterilization and transport must be arranged in a way that they deliver impeccable results. Therefore, our processes pass throughcomprehensive normative examinations that we always confirm statistically. At inpac, the validation issue starts with the cleaning process. At first, we analyze the condition of the product at the time of delivery. "Worst-case" conditions for the pre-processes are determined together with the manufacturer. These "worst-case" conditions are used to define a customized cleaning process. Only then the cleaning validation takes place which is applied to prove by ISO standards and pharmacopoeia that a clean product is the result even after an unfavorable process run and under "worst-case" conditions at the time of delivery. The same applies to the packaging processes. As soon as a packaging system has been designed for the product, we determine the parameters for the process on the basis of thestandard series ISO 11607. Process fluctuations as well as machine tolerances are considered when determining the upper and lower limits of the future process window. There, we pay attention to stability and homogeneity of the sterile barrier where its integrity is proved by dye test (ASTM F1929), burst test (ASTM F1140), and germ barrier test (ISO 11607). Our employees determine the weakest point and that's exactly where they conduct comprehensive, statistically confirmed examinations. We consider all factors that might have an influence on the stability, durability and homogeneity of the sterile barrier. In doing so, mainly the following processes are concerned: sterilization procedure transport processes storage and aging processes
For the validation of the sterilization processes, we apply the same philosophy. The practical procedure is amply standardized by harmonized standard specifications. For the sterilization with gamma rays, the standard series ISO 11137 apply where – basing on a constant bioburden and, thus, on a controlled production process – the product achieves a sterility assurance level (SAL) of 10-6. Well-defined specifications prove that the packaging order determined by the dose distribution mapping ensures an optimum radiation of the products.
For the sterilization with ethylene oxide gas, the standard series ISO 11135 apply. The implemented "overkill method" guarantees that at least 106 germs are eliminated. We furnish proof of this sterilization process by means of half-cycles in the scope of the validation. In conclusion, we conduct a residual gas determination according to ISO 10993-7 revealing that the thresholds for EO and ECH go significantly below the limits and therefore produce proof that the product sterilized with EO can be used safely.
EVERYTHING IS PROPERLY PACKED FROM THE POUCH TO THE BLISTER development of individual packaging solutions in a 3-D CAD model symbiosis of technique, esthetics, and user aspects spectroscopic characterization of the packing materials state-of-the-art high-quality machines and plants with validated processes pouches from in-house production | triple-edge chevron pouches in-line pouch packaging hard blisters from in-house production hard blisters on in-line machines soft blisters form fill seal machines label printing, flexo printing, thermotransfer printing manual cardboard packaging, cartoner validation of the packaging processes accelerated and real-time aging as well as control of the sterile barriers simulation of transport We offer in-house production of all common packaging types for medical products, e.g. hard and soft blisters as well as outer packagings. Different processes are used for the labelling of the products in order to meet the standard requirements. As a matter of course, we validate the packaging process and provide evidence for the maintenance of sterility. We examine the sterile barriers of the products after accelerated and real-time aging and simulate the transport situations in accordance with international standards in order to ensure sterility and, thus, durability of the product until needed for use.