By Application

Small molecules are the basis of classic drug development. These small molecules can be processed into drug dosage forms like tablets, capsules or syrups. These processed dosage forms needs further clinical trial, validation, quality control and testing before human consumption. To assure the safety, efficacy and potency of these drugs, proper containment like isolators and down flow booths are needed while guaranteeing operator and environment protection.

Large molecules or biologics are regarded as therapeutic proteins with an increasing significance in the medical field. The production of these macromolecules following therapeutic used is preceded by an optimization process known as protein engineering.

Antibody-drug conjugates or ADCs represent an innovative therapeutic application that combines the unique, high specificity, properties and antitumor activity of monoclonal antibodies (mAbs) that are tumor-specific but not sufficiently cytotoxic, with the potent cell killing activity of cytotoxic small molecule drugs that are too toxic to be used on their own. These cytotoxic molecules needs proper containment to assure the safety, efficacy and potency of the drug products.

Compounding is the art and science of preparing personalized medications for patients. The compounded medications are prepared based on a medical/dental doctor’s prescription. Compounding are usually done in hospitals, community pharmacies and even to other outsourcing facilities that caters the needs of other hospitals without sufficient compounding facility. To avoid the health risks and the associated economic burden of unsterile compounding, isolators are used with the proper observance of the international guidelines for compounding drugs.

Nuclear Medicine/Radiopharmacy is the branch of the profession that involves the manufacture and supply of safe and effective radiopharmaceuticals (radioactive products) for the diagnosis and therapeutic treatment of patients with cancer. Consequently, the benefits and the harmful effects of these agents co-exists with each other opting the use of lead-lined isolators and other containment methods that can block radiation.

The potential for nanomaterials to pose health or safety hazards is greater if the nanomaterials are easily dispersed (such as in powders, sprays, or droplets) or are not isolated or contained.

The concept of biocontainment in relation to laboratory biosafety and pertains to microbiology laboratories in which the physical containment of highly pathogenic organisms or agents (bacteria, viruses, and toxins) is required, usually by isolation in environmentally and biologically secure cabinets or rooms, to prevent accidental infection of workers or release into the surrounding community during scientific research.

Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) must be properly observed for the quality control of any drug product. Emphasis on sampling (sampling plan), sample handling and storage (ensuring sample integrity), testing (clear specifications and test protocols), data review and approval (primary and secondary review of raw materials), and record archiving are given with priorities all throughout the quality control procedure.

The cytotoxicity of High Potency Active Pharmaceutical Ingredients (HPAPIs), however, presents handling challenges and requires heavy investment in specialized containment to ensure that employees and their environment are protected from exposure. Negatively-pressured isolators, downflow booths, airlocks and vestibules, HVAC (heating, ventilation, and air conditioning) systems designed for single-pass air, misting showers and filtration of contaminants with safe-change filters are necessary for room requirements handling HPAPIs.

Cleanroom environments used for the production of medical devices are expected to meet the design specification in ISO 14644-4. Medical Device Cleanrooms are typically built under the cleanroom classifications ISO Class 7 and ISO Class 8 range. The manufacturing process of these products ensures that the surface of the product does not have particulate contamination when completed.

Dr. Albert Kligman of the University of Pennsylvania is described as the father of cosmeceuticals, a term he popularized. Cosmeceuticals are hybrid products which provide beyond simple cosmetic enhancement but fell short in qualifying as a pharmaceutical.

Fast-moving consumer goods (FMCG) or consumer packaged goods (CPG) are products that are sold quickly and at relatively low cost. Packaging is critical for FMCGs. The logics and distribution systems often require secondary and tertiary packaging to maximize efficiency. The unit pack or primary package is critical for product protection and shelf life but provides information and shelf life.

Hazard Analysis Critical Control Point (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. To ensure the safety of the consumer, downflow booths and other airflow containment equipment are necessary.

The Chemical Industries Association Dyes Sector group has established a system of hazard classification for all kinds of coating and colorants. They classified the chemicals as 1) nuisance dust and harmful irritant, 2) toxic (without chronic effects) and corrosive irritant, 3) harmful + may cause sensitation by inhalation or very toxic that it can cause irreversible effects and 4) very toxic + may cause cancer, genetic damage and birth defects. Depending on the coating and colorants used, the manufacturing company needs containment ranging from downflow booths, ventilated balance enclosure and other negatively-pressured isolators.

This is an industry that encompasses three main segments which include functional foods, dietary supplements, and herbal/natural products. The major concerns for company marketing nutraceuticals are to separate and purify the functional constituents for the production of ingredients and/or supplements, improve the bioavailability of the isolated nutrients (through adequate handling/processing) and improve nutrient retention during processing to ensure safety of fortified foods. Handling of nutraceuticals requires isolators, downflow booths, biological refrigerators and ovens.

In the manufacture of high-end electronics, especially in semiconductor manufacturing, the immediate presence of operators has always been an unacceptable source of contamination. Laminar flow hoods, isolators, downflow booths and other containment devices have been utilized to reduce the number of particles that can come into contact with the silicon wafers on top of the established Class 100 rooms with class 10 ratings.

From research to military and defense procedures, glove boxes are utilize in controlled environments for the handling of radioactive materials.

The automotive industry encompasses companies and activities involving manufacture of motor vehicles which include components such as engines and bodies, excluding tires, batteries, and fuel.

These cleanrooms are designed to maintain temperature, humidity, particulate, static and pressure levels. Typically, temperature and humidity as well as particulates and static can directly affect the final product. Since defects in the process can occur at any stage, the cleanliness level of the cleanroom environment must be maintained on a constant basis. Since many steps are involved in order to come to a final product, a defect along the way is not discovered until the end. It can be very costly if the cleanroom does not operate properly. Most of these cleanrooms operate in a cleanroom classification range from ISO Class 1 to ISO Class 6 with various processes occurring at different levels of cleanliness

In the case of nuclear applications, containment confines the material being worked upon and prevents the spread of toxic or radioactive contamination to the worker’s environment. Containment systems are also used in cases where experiments with trace quantities of radioactive and/or toxic material, may result in cross contamination of another part of the process. In certain processes, the atmosphere inside the containment may need to operate under special parameters, for example; inert gas environment, low relative humidity, stable temperature.

Cell and gene therapy or most commonly known as regenerative medicine is a branch of medicine that deals with restoring the structure and function of damaged tissues and organs. Moreover, the recent cell-derived regenerative medicines that cannot be terminally sterilized in their final containers, must be manufactured utilizing some form of aseptic process manufacturing. Additionally, all other product contact materials such as product containers including vials, pre-filled syringes, etc., and closures must be sterilized and fed aseptically to the equipment which fills the product and seals the container.