01.21.23 -- Aseptic Manufacturing Product Showcase

Contec offers a wide range of specially formulated chemicals for the cleaning and disinfection of critical and sterile environments. From hydrogen peroxide solutions and IPA to fast-acting validated sporicidal and broad-spectrum disinfectants, Contec has the cleaning solutions you need.

Pharmaceutical aseptic filling is all about product safety — and thus the separation of operators and pharmaceutical ingredients. Pharmaceutical isolator technology helps to build this crucial barrier. However, isolators must be integrated properly into existing lines to reveal their full potential.

The soloASEPTIC system has been designed to accommodate a variety of aseptic processes in a single-use disposable isolator. Allowing for flexibility in your facility, this system works around your needs.

Quality can never be a differentiator if it's an afterthought or a box to be checked. A complete, end-to-end digital quality management system makes quality at the source possible — and compliance issues a thing of the past.

HVLD is high voltage leak detection, a sensitive, nondestructive technology to test container closure integrity in a variety of liquid-filled pharmaceutical and medical containers including glass vials and ampoules, IV-bags, blow/fill/seal (BFS) bottles and cards and prefilled syringes. HVLD can be used to conduct CCIT on any liquid-filled product so long as the container is made of electrically insulated material and it contains an electrically conductive solution.

AseptiSafe Sterile Transfer Valves
ChargePoint Technology’s AseptiSafe range of transfer valves offers optimized product quality with increased sterility assurance, a simple in-process sterilization, and high containment performance for hazardous products.

The IsoSphere-AF is a positive pressure unidirectional airflow isolator or RABS for small-, medium-, and large-volume aseptic filling.

Parenteral products, specifically vials, both glass and, increasingly, polymeric vials, represent one of the most common package systems historically tested by helium leak detection, largely due to their continued dominance as a package system for high-potency drugs requiring utmost protection. The primary sealing interface of a traditional vial system is between the elastomeric closure and land seal of a vial, physically compressed together by a crimped aluminum seal.

The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium- and low-speed solutions, but with very high requirements. Our speed range covers up to 9,000 u/h. In this product range we can offer maximum benefits such as isolators for high containment solutions, oRABs and cRABs, IPC control with checkweighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.

For highly accurate and controlled filling and weighing of sterile liquids, our proven and reliable technology prevents costly overfilling. The easy-to-validate aseptic filling machines are compatible with all high-tech production facility equipment, software, and processes known in the pharmaceutical primary packaging industry.

Our USP <1207> and ASTM (F-3287-17) recognized mass extraction technology works on the principle of rarefied gas flow. Testing takes place in vacuum conditions to attain higher sensitivity. This patented technology type of testing is particularly suitable for pharmaceutical packaging such as IV-bags, pouches, or glass vials. Larger defects and defects as small as 1 μm can be detected with this method. The technology is thereby suitable for laboratory applications, as well as for the use in production environments, allowing stability control as well as automated 100% testing (also in inline machines).

Your future cleanroom is the most crucial asset within the entire manufacturing environment. It surrounds critical manufacturing processes where your pharma or biotech company makes its lifechanging products. The investment you make in the cleanroom facility should reduce your manufacturing risk and guarantee your performance. AES is the cleanroom expert because it's the only thing we do. Singular focus in providing the most flexible cleanroom technology solutions for over 35 years.

Many pharmaceutical applications require localized restricted access barrier systems (RABS) within the cleanroom. Germfree’s purpose-built RABS units mitigate the risk of contamination to sterile materials, containers, vials, or surfaces that may come into contact with the product. This design provides separation between personnel and product and offer many flexible options for aseptic processing when a pharmaceutical isolator is not required.

The TQS-Bottle from WIPOTEC-OCS serializes medicine bottles at high transport speeds. Serialization is carried out simply by applying labels to the bottles. The compact, space-saving footprint of the TQS-Bottle, combined with a very short design in the direction of product flow, makes it easily integrated into existing lines. Labeling is carried out in a star wheel with format-specific pockets or a driven lateral side-grip conveyor. If necessary, the system can respond to product-specific requirements with the aid of format parts. A thermal printing system ensures high-resolution printing of the labels with plain text and product codes.

Serialization solutions enabling easy tractability and tracking of individual product packages.

TSI’s cleanroom facility environmental monitoring products with built-in redundancy provide the confidence you need to reliably monitor critical processes and demonstrate compliance.

Unit-dose blow/fill/seal vials for one-time ophthalmic use have become an accepted international standard for pharmaceutical manufacturing and packaging. The ASEP-TECH Advantage is reflected in the development of formulations that no longer contain preservatives, minimizing the risk of allergic reactions for patients.

Having your commissioning agent (CxA) involved in the design phase brings value that is not realized until the project is finished. A CxA has been through many different configurations and knows what works, and what does not.

The MiniCapt Pro Remote Microbial Air Sampler from Particle Measuring Systems (PMS) incorporates the latest viable cleanroom monitoring technologies into one instrument to customize cleanroom and aseptic area microbial monitoring according to ISO Class 5/7, GMP Grade A/B, and for use in background areas monitored by a facility monitoring system (FMS).

Q: What Alconox Inc. products are listed and FDA-registered detergents?

Used Filamatic ProLINE automatic filling line, sizes ranging from fractions of a milliliter up to 260 mL, speeds up to 60 bottles/minute, consisting of 30" Packall accumulation table, model AT30, Filamatic inline two-head filler, model EconoFIL, serial# 022964, Filamatic single-head chuck capping head, model CT-100, serial# 022972, with slat conveyor, 110-120 volt, built 2016.