Isolators Selection, Design, Decontamination, and Validation
MTF is a supplier of Allograft – bone and dermal tissue. The purpose of this isolator project involves the production of Demineralized Bone Matrix (DBX) putty. DBX putty is processed human bone that has been demineralized and combined with sodium hyaluronate (HY), which is a naturally derived material not of animal origin that is both biocompatible and biodegradable. The combination of demineralized bone and sodium hyaluronate results in a putty-like consistency for ease and flexibility of use during surgical application. DBX putty is intended for use as a demineralized bone matrix for voids or gaps that are not intrinsic to the stability of the bony structure. DBX putty is indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. DBX putty can be used as follows:
• Posterolateral spine
• Ridge augmentation
• Filling of extraction sites
• Craniofacial augmentation
• Mandibular reconstruction
• Repair of traumatic defects of the alveolar ridge, excluding maxillary and mandibular fracture
• Filling resection defects in benign cysts, or other osseous defects in the alveolar ridge wall
• Filling of cystic defect
• Filling of lesions or periodontal origin
• Filling of defects of endodontic origin
DBX putty is packaged in a glass syringe and must be extruded into a sterile basin and is not injected directly into the operative site. DBX putty can be used alone or mixed with autogenous or allograft bone or with bone marrow aspirate. Since the DBX putty is introduced into the body, it must be produced and packaged under aseptic conditions and procedures. Aseptic process refers to the condition of being free from all forms of life, including bacteria, fungi, and viruses. Aseptic technique refers to efforts to maintain a sterile field during a procedure to prevent infection. These efforts include utilizing sterilized instruments and supplies and requiring staff to wear sterile gloves and other clothing, such as caps, gowns, and masks to reduce potential contamination.
The process whether conducted in either a cleanroom, biological safety cabinet, or an isolator is largely the same with the exception of the decontamination cycle. In order to maintain the highest aseptic techniques, it was decided to move the DBX putty process to isolators for their ease of use in cleaning and decontamination.
Barrier isolation technology has been recognized by the Food and Drug Administration (FDA) for a number of years as an effective method of aseptic processing. The DBX mix-fill, measuring and packaging processes were all set to be performed in isolators, decreasing the likelihood of microbial contamination. Isolators also have the added benefit of increased personal safety and comfort for the processing technicians.
Learn more about processes like these and other topics related to barrier isolators during the 24th Annual Aseptic Processing Technology Conference.
Get your questions answered by FDA for acceptable practices and how regulatory expectations are shifting by attending this conference scheduled to take place 23-24 February at the Hilton in Baltimore, Maryland register today!
Reference: Barbu, N., & Zwick, R. (2014, August 1). Isolators Selection, Design, Decontamination, and Validation. Pharmaceutical Engineering Magazine, 6-14.